Physical services

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

MRI 3 Tesla (Philips Ingenia Edition X), imaging, data acquisition, clinical

Karolinska Institutet (KI)

Centre for Imaging Research (CIR) is a world-leading imaging centre at Karolinska Institutet in Sweden in collaboration with SciLIfeLab and RISE. It offers an exceptional and unique collection of core facilities for cutting-edge structural, functional, and metabolic in vivo multimodal imaging and endovascular/minimally invasive surgical techniques. The core facility, MRI Centre, aims to catalyse novel and translational research using MRI. We offer a state-of-the-art 3 Tesla GE SIGNA Premier system-wide bore gantry and high-performance XT gradients. We support all types of MRI studies in humans, ranging from small single-centre projects to large-scale international multi-centre studies. A special focus is on offering MRI suitable for multi-modal integration such as CT, PET, EEG and MEG. The KI MRI Centre also offers a full-service lab for drawing blood and investigating psychophysiology (EDA, PPG, Eye-tracking) along with standardised image post-processing and data storage facilities with cluster computing for data analysis. In this service, we offer full support in project consultation, ethical permits and module technical support. For more information, visit the website: https://imagingresearch.se/facilities/corefacilities/mrc

Karolinska Institutet (KI)

Centre for Imaging Research (CIR) is a world-leading imaging centre at Karolinska Institutet in Sweden in collaboration with SciLIfeLab and RISE. It offers an exceptional and unique collection of core facilities for cutting-edge structural, functional, and metabolic in vivo multimodal imaging and endovascular/minimally invasive surgical techniques. The core facilities, Karolinska Experimental Research and Imaging Centre (KERIC) and the MRI Centre, aim to catalyse novel and translatory research using MRI. At KERIC, we offer a 9.4T MRI for animals such as rabbits and small piglets (see service for small animal 9.4T MRI). A state-of-the-art 3 Tesla GE SIGNA Premier system-wide bore gantry and high-performance XT gradients are available for large animal preclinical studies. We offer specialised services for large animal models as well as ex vivo imaging and support all types of MRI studies in humans, ranging from small single-centre projects to large-scale international multi-centre studies. A special focus is on offering MRI suitable for multi-modal integration such as CT, PET, EEG and MEG. The KI MRI Centre also offers a full-service lab for drawing blood and investigating psychophysiology (EDA, PPG, Eye-tracking) along with standardised image post-processing and data storage facilities with cluster computing for data analysis. In this service, we offer full support in project consultation, ethical permits, module technical support and animal technicians. For more information, visit the website: https://imagingresearch.se/facilities/corefacilities/mrc Or https://imagingresearch.se/facilities/corefacilities/keric

Karolinska Institutet (KI)

Centre for Imaging Research (CIR) is a world-leading imaging centre at Karolinska Institutet in Sweden in collaboration with SciLIfeLab and RISE. It offers an exceptional and unique collection of core facilities for cutting-edge structural, functional, and metabolic in vivo multimodal imaging and endovascular/minimally invasive surgical techniques. The core facility, MRI Centre, aims to catalyse novel and translational research using MRI. A unique next-generation clinical 7 Tesla Siemens MAGNETOM Terra.X. equipped with an ultra-high field scanner also offers cutting-edge gradient performance (130 mT/m at 250 T/m/s), parallel transmission, as well as deep learning-based acceleration and denoising for improved image quality. Micrometre resolution in vivo for microstructural imaging and layered fMRI. We support all types of MRI studies in humans, ranging from small single-centre projects to large-scale international multi-centre studies. A special focus is on offering MRI suitable for multi-modal integration such as CT, PET, EEG and MEG. The KI MRI Centre also offers a full-service lab for drawing blood and investigating psychophysiology (EDA, PPG, Eye-tracking) along with standardised image post-processing and data storage facilities with cluster computing for data analysis. In this service, we offer full support in project consultation, ethical permits and module technical support. For more information, visit the website: https://imagingresearch.se/facilities/corefacilities/mrc

Karolinska Institutet (KI)

Centre for Imaging Research (CIR) is a world-leading imaging centre at Karolinska Institutet in Sweden in collaboration with SciLIfeLab and RISE. It offers an exceptional and unique collection of core facilities for cutting-edge structural, functional, and metabolic in vivo multimodal imaging and endovascular/minimally invasive surgical techniques. The core facility Karolinska Experimental Research and Imaging Centre (KERIC), we have a preclinical 9.4T Bruker USR 94/30 MRI system. The state-of-the-art 9.4T MRI is equipped with single-mouse, single-rat, or double-mouse beds. It has three gradient bore sizes to arrange an effective inner diameter of 20cm (large animals), 12cm (medium animals) or 6cm (small animals). Methods in anatomical imaging, fMRI, Ex vivo, Pharmacological MRI and Cardiac imaging (CINE). For the mouse brain, a 4-channel phased array cry-coil drastically increased signal-to-noise. In this service, we offer full support in project consultation, ethical permits, module technical support, animal technicians and data analysis. We can host animals directly or indirectly through collaboration within KU (AKM) and other animal labs. For more information, visit the website: https://imagingresearch.se/facilities/corefacilities/keric

Karolinska Institutet (KI)

The Unit: Chemical Biology Consortium Sweden (https://www.scilifelab.se/units/cbcs/) The infrastructure is part of Science for Life Laboratory (SciLifeLab) which is an academic collaboration between Swedish universities (including Karolinska Institutet) and a national research infrastructure with a focus on life science. Chemical Biology Consortium Sweden (CBCS) is a national research infrastructure offering an extensive portfolio of services - from computational and organic chemistry to phenotypic small molecule screens in cells and model organisms, cell painting and functional precision medicine. The mission of CBCS is to provide a state-of-the-art platform and expertise for the generation of high-quality bioactive chemical tools (small organic molecules) for applications within life science research in general and with the ultimate goal to explore complex biology. Our units comprise compound handling labs (hosting the SciLifeLab Compound Collection of ca 350,000 molecules), screening labs (microtiter format liquid handling robotics and a wide range of plate readers), and chemistry labs (equipment and instrumentation for organic chemistry synthesis and analysis). The service: Access to compound collection https://www.cbcs.se/the-compound-collection The Scilifelab Compound Collection is managed by the Compound Center at CBCS KI, and is based on donations of high-quality sets from the pharmaceutical industry (Biovitrum, Karobio, Orexo/Biolipox, KDev) and has been developed and expanded with compounds from various commercial compound vendors. The compounds can be readily available in assay-ready plates through acoustic nano-litre scale liquid dispensing or in 96-tube racks; compounds are stored at 10mM concentration in DMSO solution at - 20 °C under humidity control. We provide: o Management, storage, and processing of solids and liquids. o Compound delivery and interface with key customers. o Performance of instruments and automation that support these operations. o Analytical techniques used for quality assurance. o Sample informatics, including registration and compound quality data.

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Anatomic pathology slides: preparation +/- associated patient clinical data +/- analysis +/- software evaluation +/- medical expertise; cancer, lesion, sample, biopsy, tissue, organ; histology, diagnosis, genetic; microscope, scanner

Karolinska Institutet (KI)

The Unit: Chemical Biology Consortium Sweden (https://www.scilifelab.se/units/cbcs/) The infrastructure is part of Science for Life Laboratory (SciLifeLab) which is an academic collaboration between Swedish universities (including Karolinska Institutet) and a national research infrastructure with a focus on life science. Chemical Biology Consortium Sweden (CBCS) is a national research infrastructure offering an extensive portfolio of services - from computational and organic chemistry to phenotypic small molecule screens in cells and model organisms, cell painting and functional precision medicine. The mission of CBCS is to provide a state-of-the-art platform and expertise for the generation of high-quality bioactive chemical tools (small organic molecules) for applications within life science research in general and with the ultimate goal to explore complex biology. Our units comprise compound handling labs (hosting the SciLifeLab Compound Collection of ca 350,000 molecules), screening labs (microtiter format liquid handling robotics and a wide range of plate readers), and chemistry labs (equipment and instrumentation for organic chemistry synthesis and analysis). The service: Assay development & highthroughput screening We provide expertise and technical support in the following areas: o Access to small-molecule compound libraries and robotic instrumentation. o Expertise in assay development and automation. o High-throughput screening: biochemical target-based, cell-based and phenotypic. o High-throughput imaging technology. o Computational chemistry and modelling. o Medicinal chemistry expertise. o Chemical Biology Platform. Perspective use case: Purpose The Cell Painting technology can be used to visualize many cellular parameters simultaneously, using organelle-specific fluorescent dyes and high-content imaging. This approach allows you to systematically visualize how cell morphologies react to certain stimuli, like chemical perturbations. It is thus possible to foresee in the near future that the CP technology is a valuable technology to create large systematic AI minable cell morphology resources and customized validation data sets for profiling small molecules and other treatment modalities. Development of new AI software for morphology profiling, cell segmentation for validation sets for functional perturbation assays are needed for future precision medicine. Description of service/ technology: Cell painting, high-content imaging, high-throughput screening Drug library design and delivery, cell culture and immunofluorescence staining Dataset generation, data analysis AI software development Expected outcome: New dataset generation to train AI algorithm on the different type of images generated. Improvement of AI algorithm.

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Kit preparation; reception of sample +/- inventry +/-relabelling +/- entry of additional medical data +/- managing of consents; aliquoting; ficoll; cell count viability; extraction (RNA, DNA); freezing and conservation (-150°C, -80°C, -20°C, +4°C, nitrogen); cell culture and maintenance; preparation of parafin from fresh or frozen tissues; biobank, biological sample, aliquot, storage, tissue, cell, blood, urine

Istituto Giannina Gaslini (IGG)

Motion lab data acquistion for pediatric rehabilitation

Univerzita Komenskeho V Bratislave (UK BA)

The laboratory performs research and scientific activities in the research of autonomic nervous system regulation. It uses Finometer (FMS) and Nexfin (Edwards Lifesciences) devices, which are used for non-invasive beat-to-beat blood pressure monitoring using volume-clamp method, and MedGem (Microlife) for determination of basal metabolism. It uses ECG Cardiofax 9620M (Nihon Cohden) for monitoring the electrical activity of the heart, RespiTrace (NIMS) for non-invasive respiratory monitoring by impedance method using chest and abdominal belts, CardioScreen 2000 (Medis) for non-invasive monitoring of various parameters associated with pumping function of the heart (systolic volume, systolic time intervals, etc.). It uses VaSera VS-1500N (Fukuda Denshi) characterization of arterial stiffness, EndoPAT 2000 (Itamar Medical) - characterization of endothelial dysfunction, InBody J10 (Biospace) - analysis of body composition, ECG (BTL; Pola V8) - non-invasive continuous bio signals monitoring, Finometer (Finapres medical systems), blood pressure, Flex Comp Infinity, Thought Technology for measuring the electrodermal activity, respiration, peripheral temperature, Neuroptics PLR200, pupilometry, Eyetracking (Pupil Labs) for eye movements, InBody 120 - body composition analysis.

Univerzita Komenskeho V Bratislave (UK BA)

Expertise in vitro cultivation various types of cells (human and animal), molecular analysis, imaging protocols and analysis, study design, full service measurement, academic applications. Cell culture laboratory equipment includes BSL-2 flow boxes, CO2 incubators, light microscope, cell counter; molecular laboratory equipment (RT-PCR thermocyclers, agarose/SDS-PAGE apparatus and Western blot transfers, Elisa plate reader), cellular analysis (cellular processes analyzer, fluorescent microscopy scanner.

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Who Can Benefit:** - Clinical Researchers and Investigators: For gaining insights into the feasibility of proposed studies and enhancing study designs with practical clinical input. - Healthcare Institutions: To expand research capabilities by connecting with technical and clinical experts and facilities. - Research and Development Teams: For testing new technologies or methodologies in applicable clinical contexts, ensuring innovative solutions are viable and effective. **Key Features:** - Technical Feasibility Assessment: Organizes and conducts comprehensive technical feasibility studies to evaluate the practicality and potential of clinical research projects. - Connection to Clinical Personnel: Facilitates collaboration between researchers and clinical experts at University Clinic Erlangen, ensuring access to expertise and resources necessary for study success. - Access to Real-Life and Laboratory Test Environments: Provides opportunities to conduct studies within associated clinics, leveraging previous experience in cardiology, neurology, and biomechanics to ensure practical and applicable results. **Possible Applications:** - Project Feasibility Evaluation: Assists in determining the feasibility of clinical research projects, helping to identify potential challenges and solutions early in the development phase. - Research Collaboration: Enhances research outcomes through the integration of clinical expertise and real-world testing environments, ensuring studies are rooted in clinical reality. **Who We Are:** The **Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS)** has established the **"Center for Sensor Technology and Digital Medicine" (CEMDIS)** in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through **innovative sensor technology** and **digital solutions**. This center focuses on integrating **innovative medical technologies** such as **wearables** and **robotic systems** to support **medical diagnostics**, **patient monitoring** and **evaluating patient-specific therapies** by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Hospices Civils De Lyon (HCL)

Submission to the French regulatory authorities (Ethical committee CPP, ANSM). Feedback management with these regulatory authorities to take into account their requirements.

Hospices Civils De Lyon (HCL)

Journals, Meetings, Events

Hospices Civils De Lyon (HCL)

Definition of the company needs and suggestions. Identification/access to expert medical opinion. Identifying the necessary cross-discipline professionals (inner partners and external providers) Definition of the clinical investigation methodology (number of subjects, study design, endpoints definition...) Budget proposal for the clinical investigation. Support to funding research.

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Statistical analysis plan; database consistency check; database freezing; statistical analysis (intermediate and final); writing the final statistical report.

HUMANI SC - Hospital network (HUMANI)

Comprehensive biostatistics services led by a physician biostatistician, including calculation of sample size, power calculation, data randomisation and/or analysis, to support the data-driven assessment of AI solutions maturity. This service is tailored to support the design and production of Clinical Investigation Plans (CIP) and/or Reports (CIR), Case Report Forms (CRF), as well as structured pilot reports documenting the progress of AI solutions from Technology Readiness Level (TRL) 7 to 9.

Istituto Giannina Gaslini (IGG)

Clinical consulting and testing of robots for pediatric rehabilitation: Power analysis, statistical data analysis, study design, and methodological support.

Istituto Giannina Gaslini (IGG)

Clinical consulting and testing of robots for pediatric rehabilitation: Supervision of clinical operations, medical assistance, and patient monitoring.

HUMANI SC - Hospital network (HUMANI)

Assembling the required team of cross-discipline professionals to discuss the feasibility of the project.

HUMANI SC - Hospital network (HUMANI)

Performing all monitoring activities ensuring compliance to the clinical investigation plan and regulatory requirements: site qualification/selection visit, site initiation visit, site monitoring visits, site close-out visit, site audit/inspection support

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Clinical sponsoring/monitoring/vigilance; performing all sponsoring/monitoring/vigilance activities ensuring compliance to the clinical investigation plan and regulatory requirements.

HUMANI SC - Hospital network (HUMANI)

Confidential and Non Disclosure Agreement (CNDA) signature. Listening to clinical research needs. Analyzing the international/national legal and ethical framework (laws, regulations, and ethical principles in force). Liaison with Competent Authorities (CA), experts, key-opinion leaders (KOLs), etc. (where needed). Identifying the necessary cross-discipline professionals (inner partners and external providers or vendors). Proposing comprehensive and customized solutions to optimize SMEs clinical research proposals.

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Clinical investigation set-up with patient inclusion, patient follow-up, data collection, queries management, ...; clinical investigation coordination (mono-centric or multi-centric); the hospital may be the sponsor or an associated investigation center.

HUMANI SC - Hospital network (HUMANI)

Creating and writing of investigation procedures (study procedures, standard operating procedures, monitoring plans, etc.).

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Case Report Form (CRF or e-CRF).

HUMANI SC - Hospital network (HUMANI)

Protocol development/review support. Electronic Case Report Form (CRF) design and production. Paper-CRF design and printing. Database design and set-up. CRF completion guidelines.

Istituto Giannina Gaslini (IGG)

Clinical consulting and testing of robots for pediatric rehabilitation: Data entry into software platforms, including Redcap platform usage, data lake setup, acquisition, and communication standards.

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Writing the documentation dedicated to the clinical investigation and needed for the regulatory submission: protocol, patient information letter; support to the technical file writing (including the investigator brochure) under the manufacturer responsability.

Istituto Giannina Gaslini (IGG)

Clinical consulting and testing of robots for pediatric rehabilitation: Documentation writing for clinical investigations.

HUMANI SC - Hospital network (HUMANI)

Creation and provision of essential documents required for clinical investigation implementation and performance: investigation protocol, synopis, Informed Consent Form, investigation agreement, logs, etc. Implementation of clinical investigation files : site master file, investigation sponsor files, etc.

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Clinical investigation: Methodology and synopsis; definition of the company needs and suggestions; identification/access to expert medical opinion; identifying the necessary cross-discipline professionals (inner partners and external providers); definition of the clinical investigation methodology (number of subjects, study design, endpoints definition...); budget proposal for the clinical investigation; support to funding research.

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Submission to the French regulatory authorities (Ethical committee CPP, ANSM, CNIL); feedback management with these regulatory authorities to take into account their requirements.

Istituto Giannina Gaslini (IGG)

Clinical consulting and testing of robots for pediatric rehabilitation: Data protection and ethical committee involvement.

HUMANI SC - Hospital network (HUMANI)

Assisting in regulatory submissions in compliance with applicable laws and requirements. Providing with the necessary regulatory documents. Performing regulatory submissions. Liaison with regulatory bodies: Ethics Committees (EC), Federal Agency for Medicines and Health Products (FAMHP), European Medicines Agency (EMA).

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Scientific communication/dissemination: journals, reviews, meetings, events.

Istituto Giannina Gaslini (IGG)

Clinical consulting and testing of robots for pediatric rehabilitation: Publication and dissemination of results.

HUMANI SC - Hospital network (HUMANI)

Technical feasibility study for the implementation of medical devices in acute care areas, such as operating theatres, intensive care units, etc. Support for interfacing sensors and medical devices to a data warehouse. Carry out maintenance and monitoring activities to ensure the connectivity of the device to be tested with the infrastructure and the transmission of data. Support in implementing the solution. Daily technical support for care unit beta-testers. Technical evaluation report on the solution (functionality, ergonomics, durability, etc).

Istituto Giannina Gaslini (IGG)

Clinical consulting and testing of robots for pediatric rehabilitation: Study design, model training, model assessment, infrastructure management, and data communication.

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Statistical Analysis Plan. Database consistency check. Database freezing Statistical analysis (intermediraire et final) Writing the final statistical report

Fondation De Cooperation Scientifique (IHU STRASBOURG)

• Clinical investigation set-up of the with patient inclusion, patient follow-up, data collection, queries management, ... • Clinical investigation coordination (mono-centric or multi-centric). • The IHU may be the sponsor or an associated investigation center.

Fondation De Cooperation Scientifique (IHU STRASBOURG)

• Submission to the French regulatory authorities (Ethical committee CPP, ANSM). • Feedback management with these regulatory authorities to take into account their requirements.

Hospices Civils De Lyon (HCL)

Clinical investigation set-up with patient inclusion, patient follow-up, data collection, queries management, ... Clinical investigation coordination (mono-centric or multi-centric). The hospital may be the sponsor or an associated investigation center

Hospices Civils De Lyon (HCL)

Clinical sponsoring/monitoring/vigilance. Performing all sponsoring/monitoring/vigilance activities ensuring compliance to the clinical investigation plan and regulatory requirements.

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Clinical sponsoring/monitoring/vigilance. Performing all sponsoring/monitoring/vigilance activities ensuring compliance to the clinical investigation plan and regulatory requirements

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Clinical investigation set-up of the with patient inclusion, patient follow-up, data collection, queries management, ... Clinical investigation coordination (mono-centric or multi-centric). The hospital may be the sponsor or an associated investigation center

Fondation De Cooperation Scientifique (IHU STRASBOURG)

eCRF, DMP, DVP

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Case Report Form (CRF or e-CRF)

Fondation De Cooperation Scientifique (IHU STRASBOURG)

• Discussion of the SME needs and suggestions. • Technical feasibility according the medical device maturity

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Writing the documentation dedicated to the clinical investigation and needed for the regulatory submission: protocol, patient information letter. Support to the technical file writing (including the investigator brochure) under the manufacturer responsability.

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Writing the documentation dedicated to the clinical investigation and needed for the regulatory submission: protocol, patient information letter. Support to the technical file writing (including the investigator brochure) under the manufacturer responsability.

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Clinical investigation-Methodology and synopsis Prerequisite: the medical device maturity has been defined Definition of the company needs and suggestions. Identification/access to expert medical opinion. Identifying the necessary cross-discipline professionals (inner partners and external providers) Definition of the clinical investigation methodology (number of subjects, study design, endpoints definition...) Budget proposal for the clinical investigation. Support to funding research.

Fondation De Cooperation Scientifique (IHU STRASBOURG)

• Definition of the SME needs and suggestions. • Access to expert medical opinion. • Definition of the clinical investigation methodology (number of subjects, study design, endpoints definition...) • Budget proposal for the clinical investigation. Support to funding research

Fondation De Cooperation Scientifique (IHU STRASBOURG)

• Assisting SMEs in regulatory submissions in compliance with applicable laws and requirements • Providing SMEs with the necessary regulatory documents • Liaison with regulatory bodies: Ethics Committees (EC), National Agency of Drugs Safety (ANSM)

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Submission to the French regulatory authorities (Ethical committee: CPP, ANSM). Feedback management with these regulatory authorities to take into account their requirements.

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Scientific communication/dissemination: Journals; Meetings; Events.

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Journals, Meetings, Events

Multitel (MULTITEL)

EMC Testing for product development and pre-certification for conducted emission and immunity tests. This service will be deliver in the Multitel anechoïc chamber located in Mons (Belgium). The device under test could reach 1,5 m diameter and 1 ton weight. The main standard that could be tested are relevant for electronic devices, medical devices, aeronautic devices, ... : CISPR 11/ EN55011, CISPR32/EN 55032, EN 61000-4-3, EN 60601

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

Through the established network with hospitals across Europe. In coordination with each hospital, IPN has Clinical Investigation Coordinators fully dedicated to managing clinical research. In this service, IPN identifies the requirements for testing and experimentation of the solution, presents the solution and the testing needs to partner hospitals that meet the requirements, and defines Clinical Research Teams and the Principal Investigator for future studies.

Karolinska Institutet (KI)

The Unit: CRISPR Functional Genomics (CFG) (https://www.scilifelab.se/units/crispr-functional-genomics/) The infrastructure is part of Science for Life Laboratory (SciLifeLab) which is an academic collaboration between Swedish universities (including Karolinska Institutet) and a national research infrastructure with a focus on life science. We offer a wide array of CRISPR applications, ranging from precision genome engineering in cell lines to massively parallel genetic perturbations for genetic screening and unbiased discovery. As a SciLifeLab national infrastructure unit, we strive to provide services at the cutting edge of technological innovation. Services span the entire pooled screening process, from Cas-cell line generation and library virus creation, via phenotypic selection by FACS or live/dead, to gDNA and NGS library preparation, NGS, and data analysis. Example of services provided: Precision gene-editing and functional genomic screens using various CRISPR-systems: - Cas-expressing cell line generation (Cas9, nCas9, dCas9, dCas9 fusions, Cas12a, Cas13d) - CRISPR-ko, CRISPR-inhibition, CRISPR-activation screens - Multiplexed Cas12a screens - Base-editor screens - RNA targeting screens with Cas13d. We are constantly innovating and are developing base-editing approaches for mutagenesis screens to study protein-drug interactions, as well as optical pooled screens for complex phenotypic readouts.

Univerzitna Nemocnica Martin (University Hospital Martin)

This service provides tailored datasets for evaluating AI performance in key medical specialties, including sleep disorder diagnostics, gastroenterology, digital pathology, and radiology. The datasets reflect real clinical scenarios, supporting the validation of AI algorithms and assisting organizations in achieving regulatory compliance and clinical reliability. Each dataset includes structured data and annotations designed for training, testing, and comparing AI models in various clinical contexts. Keywords: AI dataset, clinical diagnostics, digital pathology, radiology, gastroenterology, sleep disorders, performance validation.

Univerzita Komenskeho V Bratislave (UK BA)

(1) The laboratory provides microsatellite instability (MSI) in FFPE cancer tissue in low throughput screening methods, including PCR and fragment analysis. The service includes insight into technology, sample preparation, and partial or full bioinformatic data processing in GeneMapper v.6 software. (2) Next, the laboratory provides DNA methylation analysis in promoter regions of genes in low and medium throughput screening methods, including pyrosequencing and/or MS-MLPA and fragment analysis. The service includes insight into technology, sample preparation, and partial or full bioinformatic data processing in Cofalyser.net softvare. (3) The laboratory also provides comparative genomic hybridization (CGH), as well as single nucleotide polymorphism (SNP) detection by microarray that enables identification of aneuploidies, microdeletions, microduplications, as well as other types of chromosomal aberrations across the genome. The service includes insight into technology, sample preparation, and partial or full bioinformatic data processing. (4) The laboratory provides detection of single nucleotide variation from various types of samples by real-time PCR or Sanger sequencing. The method is also usefull for verification of whole genome sequencing results. The service includes insight into technology, sample preparation, and partial or full bioinformatic data processing. (5) The laboratory also provides targeted sequencing of selected parts of the genome (e.g. TruSight Oncology 500 panel), followed by somatic or germline analysis. The service includes insight into technology, sample preparation, and partial or full bioinformatic data processing in Pierian software with clinical interpretation.

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Platform:** [DPM-Research](https://www.iis.fraunhofer.de/de/ff/sse/health/mobile-health-lab/managementsystem-klinische-studien.html): A customizable eCRF platform that streamlines data and patient management and documentation in clinical studies, aligned with international standards and data protection regulations. **Who Can Benefit:** - Clinical Researchers: For streamlined data management processes that support robust research methodologies and regulatory compliance. - Regulatory Compliance Specialists: To ensure that clinical studies adhere to required international and local regulations, minimizing risk and enhancing credibility. - Healthcare Organizations: To manage clinical data effectively, improving research outcomes and operational efficiencies. **Key Features:** - Customized Data Management Solution: Provides a tailored data management and documentation platform designed to support clinical research studies. - eCRF Platform: Offers an electronic Case Report Form (eCRF) system customized for collecting and managing clinical research data efficiently. - Compliance with Standards: Ensures all studies are conducted in compliance with ISO 14155 and GDPR (DS-GVO), guaranteeing high standards in clinical investigation and data protection. **Possible Applications:** - Clinical Studies: Supports the management of clinical trial and patient data, ensuring accuracy, integrity, and regulatory compliance throughout the research lifecycle. - Data Documentation: Facilitates comprehensive data collection and documentation, improving the reliability and reproducibility of clinical research findings. **Who we are:** The **Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS)** has established the **"Center for Sensor Technology and Digital Medicine" (CEMDIS)** in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through **innovative sensor technology** and **digital solutions**. This center focuses on integrating **innovative medical technologies** such as **wearables** and **robotic systems** to support **medical diagnostics**, **patient monitoring** and **evaluating patient-specific therapies** by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

CEED - Charité Healthcare Services GmbH

With our existing product evaluations, we can review and assess products that are already on the market and used at Charité. The tests may include evaluating performance, usability, safety, or user-friendliness of the products under real or simulated use conditions. The goal is to gain precise insights into the functionality and effectiveness of the products to make informed decisions about their use and potential improvements. Additionally, if needed, interviews, service evaluations, or expert panels can be conducted to gather further insights into the current use and performance of the products. Keywords: Existing Product Analyses, Effectiveness, Efficiency, Satisfaction, Usability, Clinical Expertise, Product Improvements, Post-Market Evaluations, Surveys, Interviews

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Rental of the simulated OR and the image acquisition devices : Artis Zeego (pricing doesn't include human resources that must be present in support)

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Rental of the simulated OR and the image acquisition devices : CT SCAN (pricing doesn't include human resources that must be present in support)

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Rental of the simulated OR and the image acquisition devices : MRI (pricing doesn't include human resources that must be present in support)

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Rental of the simulated OR and the image acquisition devices : US, (pricing doesn't include human resources that must be present in support)

CEED - Charité Healthcare Services GmbH

We offer feasibility studies to investigate the viability and practicability of new product ideas or technologies. These studies assess technical, economic, and temporal aspects to determine the feasibility of a project and involve experts from various fields at Charité. The goal is to make informed decisions about the further development and implementation of innovations, based on the analysis of potential challenges and opportunities. Additionally, our Proof of Concept (PoC) studies provide the opportunity to demonstrate the fundamental feasibility and effectiveness of new concepts or technologies. Under realistic conditions, technical functionalities are validated and initial insights into the performance of the concept are gained. PoC studies are crucial for the early phase of product development as they provide a solid foundation for further research and decisions regarding the future pursuit of an idea. Keywords: Feasibility studies, Viability, Feasibility, Product ideas, Implementability, Project evaluation, Experts, Innovations, Opportunity analysis, Implementation, Proof of Concept, PoC studies, Technical functionalities, Realistic conditions, Early phase of product development, Research, Decision basis, Concept validation

Univerzita Komenskeho V Bratislave (UK BA)

Laboratory infrastructure includes flow cytometer/sorter FACS Aria II c, fluorescence microscope Olympus iX72, light microscope, BSL-2 laminar hoods, cell incubators, and electrophoretic equipment for Western blot. The laboratory develops and prepares unique in vitro models (3D and 2D cancer cell lines) derived from human tumor tissue.

Hospices Civils De Lyon (HCL)

Formative evaluation of surgical robot prototype (under development) in order to improve usability (according to IEC 62366-1). This packaged service includes : - Operating room rental - Participants (healthcare professionals) recruitment within our hospital - Protocol elaboration - User testing organization and moderation - Analysis of collected data from a human factors perspective - Evaluation report including design improvement recommendations and potential new use-related risks to mitigate Prices range is indicative and depends on testing protocol complexity and particpants number

Hospices Civils De Lyon (HCL)

Technical testing of AMR (Autonomous Mobile Robot) for logistics: - performance and acceptability in realistic environment with representative users This packaged service includes : - Room rental for testing - Participants (healthcare professionals) recruitment within our hospital if required - Protocol elaboration - Testing phase - Evaluation report, including recommendations if applicable Prices range is indicative and depends on testing protocol complexity and particpants number

Hospices Civils De Lyon (HCL)

Technical testing of surgical robot prototype in order to assess : - performance in realistic settings (using phantoms) - technical integration within operating theatre (interoperability, space constraints, etc.) This packaged service includes : - Operating room rental - Participants (healthcare professionals) recruitment within our hospital if required - Protocol elaboration - Testing phase - Evaluation report, including recommendations if applicable Prices range is indicative and depends on testing protocol complexity and particpants number

Friedrich-Alexander-Universitaet Erlangen-Nuernberg (FAU)

Services: - Full body motion analysis on a treadmill - Gait analysis with real-time feedback in virtual reality environments

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Corelab: Echocardiography expertise & proofreading, ECG, cardiology

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Human Imaging platform, imaging, multimodal; MRI 3T Magnetom Prisma Siemens, MRI Factice PST, fNIRS, EEG Brainproducts, compatible with MRI, fNIRS (near-infrared spectroscopy) NIRx, compatible with MRI, Dual/quacores blades for computing cluster (480 cores), Hybrid imaging systems (EEG/MRI, NIRS/MRI) for methods development, MRI acquisition methods development, neurofeedback protocols development, data treatment & analysis methods development; Keywords: platform, imaging, MRI 3T, fNIRS, EEG, multimodal, hybrid, neuroinformatics, neuroimaging, brain

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Test and validtation by users in simulated or real OR environment of your medical device

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Clinical acquisition of images in an OR using different imaging modality : -US -EUS -Endoscopy -MRI -CT SCAN -Artis Pheno *Clinical data collection must be included in a clinical study that IHU can design according to your needs*

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Preclinical acquisition of images in an OR using different imaging modality : -US -EUS -Endoscopy -MRI -CT SCAN -Artis Zeego *Preclinical data collection must be included in a preclinical study that IHU can design according to your needs*

Univerzita Komenskeho V Bratislave (UK BA)

Small animal MRI imaging: Bruker BioSpec 70/20 USR 7 T preclinical (MRI, MRS, MRSI, relaxometry, iron quantification, Image processing and analysis)

Univerzita Komenskeho V Bratislave (UK BA)

Cell microscopy - Confocal laser scanning microscop Zeiss LSM 880 (Fluorescence microscopy, Real-time recording, Time-resolved microscopy, Whole tissue scanning, Image processing)

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Living lab in geriatrics; platform, real world, ageing

Commissariat A L Energie Atomique Et Aux Energies Alternatives (CEA)

Neuro Imaging platform includes: -MEG/EEG (Elekta Neuromag) : 204 gradiometers, 102 magnetometers, 128 EEG channels. - MRI/MEG-compatible EEG amplifier (Brain Products) : 64 channels. - MRI 1.5T (Siemens Espree) - Audio, visual and sensitive stimulation equipment - Dedicated HPC workstation for real-time signal processing The service offers to conduct a clinical study with MEG/EEG/MRI Imaging to generate new brain-related data: - Data acquisition & analysis +/- technical expertise. - Clinical and regulatory support to set up and submit the clinical study within French regulatory framework. - Example: provide new clinical data to assess/validate the performance/robustness of an AI system in a specific intended use Keywords: Neuro Imaging; MRI; MEG; imaging data acquisition

Univerzita Komenskeho V Bratislave (UK BA)

Laboratory provides low or medium throughput screening of selected bacterial and/or viral strains from various sample material, including sample preparation to analysis by real-time PCR. The service includes insight into technology, sample preparation, and partial or full bioinformatic data processing.

Friedrich-Alexander-Universitaet Erlangen-Nuernberg (FAU)

Services: - Video and EMG-based facial expression analysis and posture detection during interventions using the mobile application - Assessment and analysis of biosignal data (EMG, ECG, and RSP) during interventions using the mobile application

Friedrich-Alexander-Universitaet Erlangen-Nuernberg (FAU)

Services: - Full body motion analysis in a stationary environment - Movement analysis in sports

Commissariat A L Energie Atomique Et Aux Energies Alternatives (CEA)

Motion laboratory rental for prototype testing : usability/technical testing and evaluation of medical device [no patients included]. Examples: Study of an exoskeleton's movements ; analysis of "fine" surgical robots mouvements. Motion lab equipped with: - 8 infrared cameras, 2 high-resolution cameras, 2 plantar pressure sensors - Wireless pressure sensors and non-invasive electromyographic sensors (system Cometa) - GAITrite system (Spatio-temporal gait parameter analysis system) - Dedicated workstation and data-storage for daily-use analysis Keywords: motion; rental; technical testing; medical device evaluation

Commissariat A L Energie Atomique Et Aux Energies Alternatives (CEA)

Within the motion analysis laboratory, this service can offer: 3D motion analysis system: - full body motion analysis - Gait analysis thanks to a full GAITrite system - definition of an anatomical model - motion sequence validation with an exoskeleton - movement tracking of robotics Data acquisition can be completed with data analysis service. Clinical and regulatory support to set up and submit the clinical study within French regulatory framework. Examples: clinical study to validate an exoskeleton on patients ; to validate a rehabilitation device on patients, ... Keywords: motion; GAIT analysis; robotics; exoskeleton; medical device validation

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Motion lab; platform, body, movement, rehabilitation, sport, ergonomics, clinical, real world, GAIT analysis

Politecnico Di Milano (POLIMI)

This service offers a 3D MULTIFACTORIAL INTEGRATED POSTURE and MOVEMENT ANALYSIS using: Optoelectronic systems; wearable inertial measurement units; Force platforms; Baropodometric platform; Surface electromyography; Metabolimeter; portable 3D Laser Scanner. This service, performed in a MOTION ANALYSIS LABORATORY, will offer: 1) DATA ACQUISITION and DATA ELABORATION relative to THE BIOMECHANICS of MOVEMENT for total body analysis (gait, posture, jump, sit to stand, …) and for specific district (upper limb assessment, trunk, hand, face, …) in the clinical/sport/ergonomics fields; 2) CLINICAL SERVICE: DATA ACQUISITION, DATA ELABORATION and REPORT CREATION for Gait Analysis test according to ESMAC standards; 3) DEVICE TESTING to verify the measurement ACCURACY; 4) COURSES and TRAINING for clinicians/technicians working in a motion analysis laboratory. Keyword: Motion Analysis, Data Acquisition, Data Elaboration, Biomechanics, Clinical, Sport, Ergonomy, Device Testing, Courses, Training

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

Movement laboratory equipped with 3D movement analysis system featuring infrared cameras and force plates. Plantar pressure sensors, isokinetic dynamometer, breath gas analyzer, ultrasonic imaging and body composition analyzer. Helping with research questions (user, customer experience, etc.) Helping with the research design and conducting the research, analysis. Video recording

Commissariat A L Energie Atomique Et Aux Energies Alternatives (CEA)

Neuro Imaging platform includes: -MEG/EEG (Elekta Neuromag) : 204 gradiometers, 102 magnetometers, 128 EEG channels. - MRI/MEG-compatible EEG amplifier (Brain Products) : 64 channels. - MRI 1.5T (Siemens Espree) - Audio, visual and sensitive stimulation equipment - Dedicated HPC workstation for real-time signal processing The service offers to conduct a clinical study with MEG/EEG/MRI Imaging to generate new brain-related data: - Data acquisition & analysis +/- technical expertise. - Clinical and regulatory support to set up and submit the clinical study within French regulatory framework. - Example: provide new clinical data to assess/validate the performance/robustness of an AI system in a specific intended use Keywords: Neuro Imaging; MRI; MEG; imaging data acquisition

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Service Keywords:** Expertise in Human Movement, Neurological Diseases, Project Design, Clinical Study Design, Scietific-Technical Constulting, Data Evaluation, Data Acquisition, Technical Support, Performance Evaluation/Reporting, **Equipment:** - 10x Vero Cameras (infrared) - 2x VUe Cameras (visible) - 2x AMTI Optima Pressure Plates - Cometa Wave Plus (EMG): 12x MiniWasve EMG Sensors, PICO EMG Sensors - 2x Blue Trident IMU (low and high g Accelerometer, Gyroscope, Magnetometer) **Who Can Benefit:** - Data Scientists and AI Researchers: To obtain high-quality datasets for training and validating AI models that can identify and predict gait abnormalities and differentiate between various movement disorders. For designing, implementing, and testing algorithms that automate the analysis of gait patterns, thereby improving efficiency and accuracy. - Healthcare Technology Innovators: To integrate AI-driven insights into wearable devices or diagnostic tools that enhance patient monitoring and care delivery. - Clinical Researchers: To explore AI applications in clinical trials, enhancing understanding of treatment impacts on gait and mobility in various disorders. - Software Developers: For creating user-friendly AI software interfaces that clinicians can use to easily interpret results and apply AI insights to patient care. - Rehabilitation Professionals: To utilize AI-enhanced feedback for developing adaptive rehabilitation protocols that respond to instrumented changes in gait patterns. - Biomedical Engineers: For advancing AI-driven biomechanical analysis tools that can be used in designing prosthetics, orthotics, and assistive devices. **Key Features:** - User-Friendly Interface: Intuitive software interface for both technical and non-technical users, ensuring ease of use for engineers, clinicians, and other healthcare personnel. - Comprehensive Reporting: Provides detailed reports and visualizations of gait characteristics, such as stride length, speed, and variability, to quantify gait patterns and draw clinically relevant conclusions. - Experienced Personnel: Gain access to a team of specialists with extensive experience in analyzing gait and movement patternsassociated with neurological conditions. Our experts possess in-depth knowledge and skills to provide accurate assessments and valuable insights, supporting the development of your application in the field of neurological disorders. - Directly Attached to Clinic: Patients and physicians can easily access the state of the art facility for gait and movement analysis. **Who We Are:** The **Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS)** has established the **"Center for Sensor Technology and Digital Medicine" (CEMDIS)** in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through **innovative sensor technology** and **digital solutions**. This center focuses on integrating **innovative medical technologies** such as **wearables** and **robotic systems** to support **medical diagnostics**, **patient monitoring** and **evaluating patient-specific therapies** by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Univerzita Komenskeho V Bratislave (UK BA)

Full-service metabolomics analysis in-vitro and ex-vivo using NMR spectroscopy. Proficiency in instrumentation performance, metabolomic measurement protocols and data analysis for clinical, academic and indystry applications.

Karolinska Institutet (KI)

The Unit: Clinical Genomics Stockholm (https://www.scilifelab.se/units/clinical-genomics-stockholm/) This infrastructure is part of Science for Life Laboratory (SciLifeLab) which is an academic collaboration between Swedish universities (including Karolinska Institutet) and a national research infrastructure with a focus on life science. Clinical Genomics Stockholm unit is a research infrastructure for large-scale, genomics-based analyses using next generation sequencing technologies. The unit assists in translational research projects, in the translation of genomics-based tools to routine clinical care and also aims to improve the capability for national microbial surveillance and for pandemic preparedness. The Service: Non-human genome sequencing Sequencing of bacterial or viral whole genomes with the possibility of sequence analysis and strain typing. Sequencing of SARS-CoV-2 amplicons. Sequencing of metagenome samples (with PCR-free protocol). This service encompasses: o Consultation (Project design, Target capture design) o Sample management o DNA& RNA sequencing (microbial genomes, metagenomics) o Bioinformatics (Bioinformatic analysis on data generated at CG) Equipment Our unit has access to specialized equipment that enable us to factilitate the translation of new high-throughput techniques into clinical use. These include, but are not restricted to: • Various automatic robotic systems (BRAVO NGS Workstation, Hamilton NGS Star) • Various systems for QC, quantification and fragment analyses (TapeStation, Quantification using fluorescent assay (Qubit, Quantit)) • Instrumentation for real time PCR and ddPCR (BioRad qPCR) • Instrumentation for Multispectral imaging (Saphyr optical mapper) • Sequencing platforms: o Illumina (NovaSeq 6000, NovaSeq 6000 Dx, NovaSeq X) o Nanopore (PromethION “access via NGI”) o PacBio (Revio)

Karolinska Institutet (KI)

The Unit: Chemical Biology Consortium Sweden (https://www.scilifelab.se/units/cbcs/) The infrastructure is part of Science for Life Laboratory (SciLifeLab) which is an academic collaboration between Swedish universities (including Karolinska Institutet) and a national research infrastructure with a focus on life science. Chemical Biology Consortium Sweden (CBCS) is a national research infrastructure offering an extensive portfolio of services - from computational and organic chemistry to phenotypic small molecule screens in cells and model organisms, cell painting and functional precision medicine. The mission of CBCS is to provide a state-of-the-art platform and expertise for the generation of high-quality bioactive chemical tools (small organic molecules) for applications within life science research in general and with the ultimate goal to explore complex biology. Our units comprise compound handling labs (hosting the SciLifeLab Compound Collection of ca 350,000 molecules), screening labs (microtiter format liquid handling robotics and a wide range of plate readers), and chemistry labs (equipment and instrumentation for organic chemistry synthesis and analysis). The service: Open access to instrumentation Possibility to rent specialised laboratory equipments, and also to get your own equipment tested by our team of scientists and lab experts. Scientific writing support and reporting can also be offered if needed.

Commissariat A L Energie Atomique Et Aux Energies Alternatives (CEA)

Conduct an interventional clinical study within clinical research facility CEA-Clinatec : Operating room and hospitalisation room, with access to Grenoble-Alpes University Hospital's network of clinicians. Clinical and regulatory support to set up and submit the clinical study within French regulatory framework. Operating room equipped with: - Neuro navigation robotic system ROSA - Intraoperative 1,5T MRI (Espree, Siemens): positioned on a rail to go into the operating room during surgery - Mobile X-ray unit (general Electric) - Stereotaxis interventional radiography chain (Apelem) Keywords: operating room; clinical study; surgery; neurology; medical device validation

Commissariat A L Energie Atomique Et Aux Energies Alternatives (CEA)

Facility rental for: - protoype testing: usability/technical testing and evaluation of medical device [no patients included] - MRI compatibility evaluation of medical devices Rental of the operating room including: - surgical and anesthesic equipment MRI-compatible - anesthesic area - hospitalisation rooms if needed OR equipped with: - Neuro navigation robotic system ROSA - Intraoperative 1,5T MRI (Espree, Siemens): positioned on a rail to go into the operating room during surgery - Mobile X-ray unit (general Electric) - Stereotaxis interventional radiography chain (Apelem) Keywords: operating room; medical device evaluation

Karolinska Institutet (KI)

Centre for Imaging Research (CIR) is a world-leading imaging centre at Karolinska Institutet in Sweden in collaboration with SciLIfeLab and RISE. It offers an exceptional and unique collection of core facilities for cutting-edge structural, functional, and metabolic in vivo multimodal imaging and endovascular/minimally invasive surgical techniques. The core facility, neuronal brain activity using magnetoencephalography (NatMEG). NatMEG is Sweden's first and only research laboratory for whole-head measurements of neuronal brain activity using MEG. The state-of-the-art On-scalp MEG promises improved sensitivity and spatial precision compared to traditional cryogenic MEG. The system uses 128 novel optically pumped magnetometer (OPM) sensors and will be the first of its kind in the world. It includes 32 digital trigger channels, 8 bipolar analogue input and 8 bipolar output channels that are recorded along with the MEG data with integrated 128-channel EEG for simultaneous measurement. Due to the flexibility of OPMs, the sensors can also be used to record other electrophysiological signals, such as magnetocardiography (MCG), magnetomyography (MMG) and magnetoretinography (MRG). All MEG recordings are done inside a Vacuumschmelze GmbH Ak3B magnetically shielded room (MSR) with 2 high-permeability layers. The inside dimensions of the MSR are approximately 3m x 4m x 2.5m. In this service, we offer full support in project consultation, ethical permits and module technical support. For more information, visit the website: https://www.natmeg.se/

Istituto Giannina Gaslini (IGG)

Living lab for pediatric rehabilitation

Karolinska Institutet (KI)

Centre for Imaging Research (CIR) is a world-leading imaging centre at Karolinska Institutet in Sweden in collaboration with SciLIfeLab and RISE. It offers an exceptional and unique collection of core facilities for cutting-edge structural, functional, and metabolic in vivo multimodal imaging and endovascular/minimally invasive surgical techniques. The core facility, the Brain Molecular Imaging Centre (BMIC), supports clinical and pre-clinical research studies involving PET experiments. For large animal preclinical studies: the GE Discovery MI 5 PET/CT is a whole-body PET system designed for increased field of view to enable exceptionally high sensitivity, allowing AI, deep learning image reconstruction. The PET system is mainly used in humans and larger animals such as pigs. The system specifications are Transaxial FOV: 70 cm, Axial FOV: 25 cm, Spatial resolution: ~5 mm. Radiopharmacy CF, we then provide full service in conducting PET experiments. In this service, we offer our highly trained staff comprising PET camera operators, medical physicists, research nurses and physicians, as well as specialised staff conducting experiments with animals. For more information, visit the website: https://imagingresearch.se/facilities/corefacilities/bmic

Karolinska Institutet (KI)

Centre for Imaging Research (CIR) is a world-leading imaging centre at Karolinska Institutet in Sweden in collaboration with SciLIfeLab and RISE. It offers an exceptional and unique collection of core facilities for cutting-edge structural, functional, and metabolic in vivo multimodal imaging and endovascular/minimally invasive surgical techniques. The core facility Karolinska Experimental Research and Imaging Centre (KERIC), has two PET-CT systems for animal imaging (Mediso nanoScan PET-CT). They are equipped with single-mouse, single-rat, or double-mouse beds. Four mice can be run simultaneously with exceptional image quality. The PET modules (spatial resolution 0.8mm) and a CT module (min. voxel size: 10-34 µm). KERIC collaborates closely with the Radio Pharmacy Core Facility (RCF), which allows us to deliver freshly produced radioactive ligands within a minimum time frame. In this service, we offer full support in project consultation, ethical permits, module technical support, animal technicians and data analysis. We can host animals directly or indirectly through collaboration within KU (AKM) and other animal labs. For more information, visit the website: https://ki.se/en/research/pet

Karolinska Institutet (KI)

Centre for Imaging Research (CIR) is a world-leading imaging centre at Karolinska Institutet in Sweden in collaboration with SciLIfeLab and RISE. It offers an exceptional and unique collection of core facilities for cutting-edge structural, functional, and metabolic in vivo multimodal imaging and endovascular/minimally invasive surgical techniques. The core facility, the Brain Molecular Imaging Centre (BMIC), supports both clinical and pre-clinical research studies involving PET experiments. For human PET/CT imaging, the GE Discovery MI 5 PET/CT is a whole-body PET system designed for increased field of view to enable exceptionally high sensitivity, allowing AI deep learning image reconstruction. The PET system is mainly used in humans but can also be used for larger animals such as pigs. The system specifications are Transaxial FOV: 70 cm, Axial FOV: 25 cm, Spatial resolution: ~5 mm. Radiopharmacy CF, we then provide full service in conducting PET experiments. Our highly trained staff is comprised of PET camera operators, medical physicists, research nurses and physicians, as well as specialised staff conducting experiments in animals. For more information, visit the website: https://imagingresearch.se/facilities/corefacilities/bmic

Karolinska Institutet (KI)

Centre for Imaging Research (CIR) is a world-leading imaging centre at Karolinska Institutet in Sweden in collaboration with SciLIfeLab and RISE. It offers an exceptional and unique collection of core facilities for cutting-edge structural, functional, and metabolic in vivo multimodal imaging and endovascular/minimally invasive surgical techniques. The core facility Karolinska Experimental Research and Imaging Centre (KERIC), we have a preclinical 9.4T Bruker USR 94/30 MRI combined with Mediso nanoScan PET-CT systems for small-animal imaging equipped with single-mouse, singe-rat, or double-mouse beds. The PET module has a spatial resolution of 0.8mm. The state-of-the-art 9.4T MRI is equipped with three gradient bore sizes to arrange an effective inner diameter of 20cm (large animals), 12cm (medium animals) or 6cm (small animals). Methods in anatomical imaging, fMRI, Ex vivo, Pharmacological MRI and Cardiac imaging (CINE). For the mouse brain, a 4-channel phased array cry-coil drastically increased signal-to-noise. KERIC collaborates closely with the Radio Pharmacy Core Facility (RCF), which allows us to deliver freshly produced radioactive ligands within a minimum time frame. In this service, we offer full support in project consultation, ethical permits, module technical support, animal technicians and data analysis. We can host animals directly or indirectly through collaboration within KU (AKM) and other animal labs. For more information, visit the website: https://imagingresearch.se/facilities/corefacilities/keric

RISE Research Institutes Of Sweden

RISE Research Institutes of Sweden AB in Södertälje works with pharmaceutical R&D including preclinical research of new candidate drugs. From design to production in the same testbed: - Preclinical in-vitro and in-vivo studies to study target and non-target toxicology. - Drug formulation and new therapies with small molecules, biologics including proteins, oligonucleotides, peptides, mRNA, DNA etc. - Chemical Process development and GMP production to clinical studies. - In vivo studies integrated with bioanalytical and pathology services, supporting from early discovery to preclinical safety testing. - Chemical analysis and characterization, including impurity analysis and stability. - Green chemicals and formulation. Keywords: Testbeds, toxicology, regulatory safety, process chemistry, drug delivery, drug formulation, drug synthesis, bioassay, drug analysis

Unidade Local De Saúde De Coimbra EPE (ULS Coimbra EPE)

Clinical investigations involve rigorous testing of AI technologies or healthcare solutions in real-world clinical environments. The investigation involves one or more human subjects, and the goal is to assess the clinical performance, effectiveness or safety of a medical device. ULS Coimbra act as an Investigation site, providing: - Principal invistigatior qualified by education, training and experience - Trained research staff - Acess to specific patient population - Site facilities that comply with requeriments of intended use of device - Hospital Ethics Comittee submission - Site selection report documenting qualifications of the principal investigator and the suitability of the investigation site This service can be complemented with the support of CRO services.

Centro Hospitalar De Sao Joao Epe (CHSJ)

Clinical investigations involve rigorous testing of AI technologies or healthcare solutions in real-world clinical environments. The investigation involves one or more human subjects, and the goal is to assess the clinical performance, effectiveness or safety of a medical device. ULS São João act as an Investigation site, providing: - Principal invistigatior qualified by education, training and experience - Trained research staff - Acess to specific patient population - Site facilities that comply with requeriments of intended use of device - Hospital Ethics Comittee submission - Site selection report documenting qualifications of the principal investigator and the suitability of the investigation site This service can be complemented with the support of CRO services.

Centro Hospitalar De Sao Joao Epe (CHSJ)

ULS São João performs comprehensive functional testing to evaluate the performance and integration of healthcare technologies within clinical environments. The testing is carried out in order to ensure that the solution delivers its intended functions, seamless integrates with existing infraestructures and devices and maintains reliable performance under normal or demanding usage conditions. This packaged service includes: - Key functionality verification; - Real-world performance testing; - Integration with existing systems and devices; - Evaluation report including suitability for the clinical environment.

Unidade Local De Saúde De Coimbra EPE (ULS Coimbra EPE)

ULS Coimbra performs comprehensive functional testing to evaluate the performance and integration of healthcare technologies within clinical environments. The testing is carried out in order to ensure that the solution delivers its intended functions, seamless integrates with existing infraestructures and devices and maintains reliable performance under normal or demanding usage conditions. This packaged service includes: - Key functionality verification; - Real-world performance testing; - Integration with existing systems and devices; - Evaluation report including suitability for the clinical environment.

Centro Hospitalar De Sao Joao Epe (CHSJ)

Formative usability testing is not intended to evaluate the safety and performance of a device comprehensively. This services focus on an Iterative process where usability tests are carried out early and repeatedly during the development of the device. The goal of this service is to identify and correct any usability problems before the device is finalized, this means: Early identification of problems;Iteration and feedback; User involvement; Focus on improvement.

Unidade Local De Saúde De Coimbra EPE (ULS Coimbra EPE)

Formative usability testing is not intended to evaluate the safety and performance of a device comprehensively. This services focus on an Iterative process where usability tests are carried out early and repeatedly during the development of the device. The goal of this service is to identify and correct any usability problems before the device is finalized, this means: Early identification of problems;Iteration and feedback; User involvement; Focus on improvement.

Centro Hospitalar De Sao Joao Epe (CHSJ)

Summative usability testing assesses the final product’s usability and compliance with regulatory standards. The main objective is to evaluate the overall usability performance of the device, and not necessarily to identify specific problems to be corrected. This service ensures that the technology meets the needs of end-users, and aligns with clinical workflows.This packaged service can include: - Participants (healthcare professionals) recruitment within our hospital - Protocol elaboration - User testing organization and moderation - Analysis of collected data from a human factors perspective - Evaluation report including design improvement recommendations and potential new use-related risks to mitigate

Unidade Local De Saúde De Coimbra EPE (ULS Coimbra EPE)

Summative usability testing assesses the final product’s usability and compliance with regulatory standards. The main objective is to evaluate the overall usability performance of the device, and not necessarily to identify specific problems to be corrected. This service ensures that the technology meets the needs of end-users, and aligns with clinical workflows.This packaged service can include: - Participants (healthcare professionals) recruitment within our hospital - Protocol elaboration - User testing organization and moderation - Analysis of collected data from a human factors perspective - Evaluation report including design improvement recommendations and potential new use-related risks to mitigate

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Equipment:** - PHCT Mobile Gaitlab System Clinic: A complete mobile setup for detailed and accurate gait analysis, designed specifically for clinical use cases and supporting the aforementioned features and applications. - maphera®: A Fraunhofer technology revolving around easy and mobile acquisition of multimodal, patient-centered data in medical grade quality. Current sensors include ECG, PPG, EMG, IMU and any other modality you require, due to the flexible sensor interface of the maphera® system. - Polar H10 and Pro Strap: Long-term, mobile monitoring of heart rate and movement of subjects during any kind of activity in a real-world environment. **Who Can Benefit:** - Data Scientists and AI Researchers: Gain reliable datasets for developing AI models to identify and predict health abnormalities, enhancing the accuracy and efficiency of analysis. - Healthcare Technology Innovators: Integrate AI insights into wearable devices or diagnostic tools, advancing patient monitoring technologies. - Clinical Researchers: Employ AI applications in clinical trials to deepen insights into the effects of treatments on a multitude of physical disorders. - Software Developers: Create and refine user-friendly AI interfaces for clinicians, enabling effective application of AI-generated insights in patient care. - Rehabilitation Professionals: Leverage AI-enhanced feedback to craft adaptive rehabilitation strategies responsive to real-time biosignal analysis. - Biomedical Engineers: Innovate AI-driven biomechanical tools for the design of prosthetics, orthotics, and assistive devices. **Key Features:** - Portability: Designed for easy transport and quick setup in clinical or any other environment. - Real-Time Data Collection: Offers acquisition of highly synchronized multimodal data in a raw format for developing state of the art algorithms. - User-Friendly Interface: Simplifies operation for both technical and non-technical users, including engineers and healthcare personnel. - Comprehensive Reporting: Delivers detailed reports on gait characteristics such as stride length, speed, and balance for thorough clinical evaluations. - Expert Personnel: Specialists with extensive experience in analyzing gait and movement disorders, particularly those related to Parkinson's disease, to provide accurate assessments and insightful analysis for informed diagnoses and treatment planning. **Possible Applications:** - Algorithm Validation: Supplies precise and repeatable gait data essential for the evaluation of therapeutic interventions. - Multimodal Data Acquisition: Acquire medical grade data of various biosignals like ECG, EMG, motion or PPG (further sensor frontends in development). - Identify Relevant Modality: Identify the most relevant biosignal for your use case to acquire and use only relevant data in your application. - Fast Prototyping: Aside from your algorithm, you can validate your innovative wearable sensor technology and synchronize it to data from traditional sensor frontends. **Who We Are:** The **Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS)** has established the **"Center for Sensor Technology and Digital Medicine" (CEMDIS)** in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through **innovative sensor technology** and **digital solutions**. This center focuses on integrating **innovative medical technologies** such as **wearables** and **robotic systems** to support **medical diagnostics**, **patient monitoring** and **evaluating patient-specific therapies** by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Service Keywords:** Psychological Studies, Affective Sensing, Multimodal Data, Stress/Emotion Detection, Project Design, Clinical Study Design, Scientific-Technical Consulting, Data Evaluation, Data Acquisition, Technical Support, Performance Evaluation/Reporting **Equipment:** - Expo-Box: Provides a controlled environment specifically designed for psycho-physiological studies. - Video Monitoring System: Captures behavioral indicators and emotional expressions for comprehensive analysis. - BioPac System: Measures ECG, respiration, oximetry, EEG, EMG, and skin temperature for detailed physiological monitoring. - AntNeuro EEG: Offers high-resolution brain activity monitoring for in-depth neurological assessments. - Tobii Eye Tracker: Tracks eye movements to infer cognitive and emotional states. - SHORE Facial Expression Extraction: Analyzes facial expressions to determine emotional cues and responses. **Who Can Benefit:** - Psychologists and Behavioral Scientists: For conducting detailed studies on emotional and stress responses to enhance understanding of human behavior. - Neuroscientists: To explore the neurological underpinnings of emotions and stress-related disorders. - Healthcare Professionals: To develop and test interventions aimed at improving emotional regulation and stress management in patients. - Technical Innovators: To design and refine affective sensing technologies in various applications such as wearable devices and therapeutic tools. - Research Institutions: For collaborative projects that require cutting-edge technology and expert guidance in psycho-physiological research. **Key Features:** - Multimodal Emotion Analysis: Specializes in the comprehensive assessment of emotional states through various physiological and behavioral indicators, including affective sensing and stress evaluation. - Controlled Environment: Offers a controlled setting ideal for psycho-physiological studies, enabling precise measurement and analysis of emotional responses. - Advanced Monitoring: Utilizes state-of-the-art equipment for detailed bio-monitoring and emotional analysis to support psychological research and clinical applications. - Expert Support: Provides expert assistance in recording high-quality data, assessing the feasibility of studies, and conducting patient and subject research across diverse fields, including automotive, art, and video games. **Possible Applications:** - Psychological Studies: Facilitates research into emotional responses and stress management, supporting the development of new psychological theories and therapeutic approaches. - Clinical Research: Assists in the design and execution of clinical trials focused on the psycho-physiological aspects of emotional disorders. - Affective Sensing: Supports the development and validation of technologies aimed at detecting and interpreting emotions in real-time. **Who we are:** The **Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS)** has established the **"Center for Sensor Technology and Digital Medicine" (CEMDIS)** in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through **innovative sensor technology** and **digital solutions**. This center focuses on integrating **innovative medical technologies** such as **wearables** and **robotic systems** to support **medical diagnostics**, **patient monitoring** and **evaluating patient-specific therapies** by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Friedrich-Alexander-Universitaet Erlangen-Nuernberg (FAU)

Services: - Synchronized measurement and recording of radar and reference signals in the body

Univerzitna Nemocnica Martin (University Hospital Martin)

Leverage the hospital's extensive operational expertise and infrastructure to evaluate your product in both simulated and real-world hospital environments. This service focuses on assessing logistics, flow management, and process efficiency, providing SMEs with detailed feedback on the performance and compatibility of their solutions within hospital workflows. Keywords: real-world testing, hospital settings, departments, expert opinion

Univerzita Komenskeho V Bratislave (UK BA)

The laboratory provides detection of RNA expression in low, medium and high throughput screening methods, including real-time PCR or microarray (MA). In additon, it provides detection of miRNA expression in low, as well as in high throughput screening meethods, including real-time PCR (qPCR) or microarray (MA). The service includes insight into technology, sample preparation, and partial or full bioinformatic data processing.

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Scanner (Canon & Siemens), imaging, data acquisition, clinical

HUMANI SC - Hospital network (HUMANI)

Design and writing of communication support in compliance with editorial and scientific guidelines for publication (journals, meetings, events...).

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Who Can Benefit:** - Clinical Researchers: For strengthening study designs and hypotheses with a comprehensive understanding of existing literature. - Medical Product Developers: To advance the development of innovative medical solutions by integrating scientific research insights. - Academics and Healthcare Professionals: For engaging in scholarly dissemination of research, raising the profile and recognition of their work. **Key Features:** - Systematic Literature Research: Conducts comprehensive, literature searches to establish the scientific foundation for clinical investigation plans, regulatory submissions, and product positioning. - Clinical Investigation Plan (CIP) Development: Authors complete, ISO 14155-compliant study plans including objectives, design, endpoints, visit schedules, and statistical considerations. - Data Management Planning: Develops detailed DMPs covering database design, data collection procedures, validation rules, coding dictionaries, and quality assurance workflows. - Biostatistical Analysis: Provides full statistical support from sample size calculation and analysis plan development through to confirmatory analysis, subgroup evaluations, and results interpretation. - Clinical Investigation Report (CIR): Produces comprehensive final study reports documenting methods, results, and conclusions in accordance with ISO 14155 and regulatory expectations. - Scientific Dissemination & Publication: Supports or leads the preparation of peer-reviewed manuscripts, conference abstracts, and strategic dissemination planning. - Product Development Guidance: Translates scientific evidence into actionable recommendations for medical product design, differentiation, and clinical positioning. **Possible Applications:** - MDR Clinical Evaluation Support: Conducting systematic literature reviews and writing clinical evaluation reports (CER) to fulfill MDR Annex XIV requirements for medical device certification. - Planning Investigator-Initiated Trials: Developing robust CIPs and DMPs for academic research groups conducting clinical studies on novel sensor technologies or digital health solutions. - Regulatory Submission Documentation: Producing the complete documentation package (CIP, SAP, DMP, CIR) required for notified body review or competent authority submissions. - Biostatistical Consulting for MedTech Startups: Providing sample size calculations, endpoint selection guidance, and analysis strategies for companies designing their first clinical study. - Multi-Center Study Coordination: Harmonizing documentation, data management, and statistical reporting across multiple investigational sites. - Scientific Visibility for Industry Partners: Transforming proprietary study results into high-impact publications, raising the scientific profile of commercial innovations. - Grant Proposal Support: Strengthening research funding applications with solid literature foundations, well-designed study concepts, and credible statistical frameworks. **Who We Are:** The **Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS)** has established the **"Center for Sensor Technology and Digital Medicine" (CEMDIS)** in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through **innovative sensor technology** and **digital solutions**. This center focuses on integrating **innovative medical technologies** such as **wearables** and **robotic systems** to support **medical diagnostics**, **patient monitoring** and **evaluating patient-specific therapies** by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

"From home to hospital", Simulated hospital. Rental of the Simulation rooms, audio and video recording. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting the research, analysis. User testing.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

"From home to hospital", Simulated hospital. Rental of the Simulation rooms, audio and video recording. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting the research, analysis. User testing.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

"From home to hospital", Simulated hospital. Rental of the Simulation rooms, audio and video recording. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting the research, analysis. User testing.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

Rental of the Simulation rooms, audio and video recording. Cameras, projectors for 4 sides; Acciden site simulation. "From home to hospital" Simulated hospital. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting research, analysis. User testing.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

"From home to hospital", Simulated hospital. Rental of the Simulation rooms, audio and video recording. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting the research, analysis. User testing.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

"From home to hospital", Simulated hospital. Rental of the Simulation rooms, audio and video recording. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting the research, analysis. User testing.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

"From home to hospital", Simulated hospital. Rental of the Simulation rooms, audio and video recording. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting the research, analysis. User testing.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

"From home to hospital", Simulated hospital. Rental of the Simulation rooms, audio and video recording. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting the research, analysis. User testing.

Fondation De Cooperation Scientifique (IHU STRASBOURG)

8 clinical Operating Rooms 5 simulated Operating Rooms (preclinical)

Karolinska Institutet (KI)

Centre for Imaging Research (CIR) is a world-leading imaging centre at Karolinska Institutet in Sweden in collaboration with SciLIfeLab and RISE. It offers an exceptional collection of core facilities for cutting-edge structural, functional, and metabolic in vivo multimodal imaging and endovascular/minimally invasive surgical techniques. The core facility Karolinska Experimental Research and Imaging Centre (KERIC) offers simulated environmental operating rooms for surgical training and medical and robotic device testing. KERIC is a joint university- and hospital facility that gives you access to expert surgeons, medical doctors, technicians and researchers expertise. The four operation units are equipped with: • Anaesthesia equipment (Dräger Primus Infinity) • Monitoring equipment (Datex / Philips MX800) • Operating table (TruSystem 7000) • Surgical diathermy (Valleylab, ForceTriad) • Surgical light (Maquet Volista) • Patient warming units (Mistral Air) • Surgical suction • Standard surgical instruments Our operating rooms are regularly used for surgical training in transplantation, neuro/stroke, pediatric surgery, specialist trauma expertise, otorhinolaryngology, gynaecology, and pediatric surgery. In this service, we offer full support in project consultation, ethical permits, module technical support, expert surgeons, animal technicians and data analysis. We can host animals directly or indirectly through collaboration within KU (AKM) and other animal labs. For more information, visit the website: https://ki.se/en/research/research-infrastructure-and-environments/core-facilities-for-research/keric/experimental-surgery

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

"From home to hospital", Simulated hospital. Rental of the Simulation rooms, audio and video recording. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting the research, analysis. User testing.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

"From home to hospital", Simulated hospital. Rental of the Simulation rooms, audio and video recording. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting the research, analysis. User testing.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

Rental of the Simulation rooms, audio and video recording. Cameras, projectors for 4 sides. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting research, analysis. User testing. "From home to hospital" Simulated hospital.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

"From home to hospital", Simulated hospital. Rental of the Simulation rooms, audio and video recording. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting the research, analysis. User testing.

Hospices Civils De Lyon (HCL)

Rental of the surgical facility (130m²), including: - a simulated operating room, with audio-video recording of testing sessions - an observation room with audio-video controls - a meeting room for debriefing, focus group , etc. - a convivial space to welcome participants

Multitel (MULTITEL)

EMC Testing for product development and pre-certification for radiated emission and immunity (EMC, radiated emission and immunity). This service will be deliver in the Multitel anechoïc chamber located in Mons (Belgium). The device under test could reach 1,5 m diameter and 1 ton weight. For both radiated emission and immunity, we cover standard for classical device industrial, scientific and medical and large consumer electronic device (CISPR11/CISPR32/EN 61000-4-3). Others standard for specific domain (spatial, military, avionics, automotive, railway) can be covered by Multitel equipment. ETSI communication tests are mandatory for wireless device (Bluetooth, Wifi, Nb-IOT, xG, ..). For these wireless devices, commercial modem are usually used. These modems are itself certified but with a restricted way of used (antenna for example). So ETSI tests has to be passed with the full device. Arguing modem certified to justify device certification is not fully relevant. Multitel provides ETSI pre-tests also (ETSI, wireless, communication test, CE marking).

Karolinska Institutet (KI)

The Unit: Eukaryotic Single Cell Genomics (https://www.scilifelab.se/units/eukaryotic-single-cell-genomics/) The infrastructure is part of Science for Life Laboratory (SciLifeLab) which is an academic collaboration between Swedish universities (including Karolinska Institutet) and a national research infrastructure with a focus on life science. Single-cell genomics technologies are rapidly advancing and have proven to give new insights into cell type discovery and in the characterization of heterogeneity in tumors as well as in normal tissue. The Eukaryotic Single Cell Genomics (ESCG) unit aims at providing high-throughput single cell transcriptomics services through a streamlined and complete single-cell RNA sequencing service. The user provide us with single cells, we process the samples, sequence and deliver annotated gene expression data. • Study heterogeneity within putatively homogeneous cell populations • Unbiased discovery of cell types in complex tissues • Characterizing the cellular and genetic composition of tumors The service: Single Cell Multiomic profiling 10X Genomics (droplet-based) single cell RNA sequencing in combination with single cell immune profiling (VDJ), AND/OR in combination with cell surface protein detection, OR in combination with ATAC (Assay for Transposase Accessible Chromatin) to analyze thousands of unique open chromatin fragments genome-wide with single cell resolution. ESCG provides access to technology, end-to-end support from help with project planning, quality check of your sample, cDNA library preparation to analysis and associated bioinformatics support.

Karolinska Institutet (KI)

The Units: CRISPR Functional Genomics (CFG) (https://www.scilifelab.se/units/crispr-functional-genomics/) and Eukaryotic Single Cell Genomics (ESCG) (https://www.scilifelab.se/units/eukaryotic-single-cell-genomics/) Both infrastructures are part of Science for Life Laboratory (SciLifeLab) which is an academic collaboration between Swedish universities (including Karolinska Institutet) and a national research infrastructure with a focus on life science. Both units, CFG and ESCG, have designed a pipeline of CRISPR pooled screens together with single cell RNASeq readout (Perturb-Seq, CROP-Seq). This allows to assess gene expression phenotypes at the single cell level following inactivation of a pool of genes, using Cas-9 expressing cells. Service span the entire pooled screening process, from Cas-cell line generation and library virus creation, via phenotypic selection by FACS or live/dead, to single cell library preparation, NGS and data analysis.

Karolinska Institutet (KI)

The Unit: Eukaryotic Single Cell Genomics (https://www.scilifelab.se/units/eukaryotic-single-cell-genomics/) The infrastructure is part of Science for Life Laboratory (SciLifeLab) which is an academic collaboration between Swedish universities (including Karolinska Institutet) and a national research infrastructure with a focus on life science. Single-cell genomics technologies are rapidly advancing and have proven to give new insights into cell type discovery and in the characterization of heterogeneity in tumors as well as in normal tissue. The Eukaryotic Single Cell Genomics (ESCG) unit aims at providing high-throughput single cell transcriptomics services through a streamlined and complete single-cell RNA sequencing service. The user provide us with single cells, we process the samples, sequence and deliver annotated gene expression data. • Study heterogeneity within putatively homogeneous cell populations • Unbiased discovery of cell types in complex tissues • Characterizing the cellular and genetic composition of tumors The service: Single cell RNA sequencing (scRNA-seq) Depending on your sample and your need, we can offer single-cell RNA sequencing using SMART-Seq3 or 10X Genomics methods on live cells, and 10X Genomics FLEX assay on fixed cells (recommended for users outside Stockholm area). SMART-Seq3 alows full-length transcript information at a higher sensitivity compared to 10X Genomics technology (10X Genomics: generates data starting from 3' or 5' end of your transcript of interest). However, 10X Genomics has a higher cell throughput and lower cost per cell compared to Smart-seq3. Sequencing equipment: Illumina NextSeq or NovaSeq platforms. ESCG provides access to technology, end-to-end support from help with project planning, quality check of your sample, cDNA library preparation to analysis and associated bioinformatics support. Prospective Use case: Single cell transcriptomics can be used in the clinic to understand heterogeneity of cancer sub-clonal population, and potentially to follow how these different sub-clones respond differently to various therapeutic treatments. Therefore, AI algorithms trained on such datasets could help clinical decision-making process for molecular-targeted therapies.

Friedrich-Alexander-Universitaet Erlangen-Nuernberg (FAU)

Services: - Full-scale sleep analysis and sleep staging using polysomnography - Assessment of sleep disorders and disturbances, like sleep apnoea, snoring, restless-leg/arm syndrome, etc. - Analysis of facial expressions during sleep - Contactless measurement of heart rate and respiration

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Who Can Benefit:** - Clinical Researchers and Study Designers: For leveraging AI capabilities to refine and finalize study protocols, enhancing their effectiveness and feasibility. - Medical Product Developers: To assess the clinical viability of new products and solutions, ensuring they meet necessary evaluation criteria before market introduction. - Research and Development Teams: For innovative project development utilizing cutting-edge AI technologies to optimize research outcomes. **Key Features:** - AI-Driven Protocol Parsing: Leverages artificial intelligence to automatically parse, structure, and analyze clinical study protocols, extracting key parameters and identifying inconsistencies or gaps. - Feasibility Assessment: Conducts detailed evaluations to determine the viability of clinical studies for medical products, ensuring alignment with research goals and regulatory standards. - Design Optimization Recommendations: Generates actionable suggestions for protocol refinement – from endpoint selection and visit schedules to sample size considerations and risk mitigation. - Regulatory Alignment Check: Automatically flags protocol elements that may conflict with applicable standards (ISO 14155, MDR, ICH-GCP) or require additional justification. - Expert-in-the-Loop Guidance: Combines AI-generated insights with human expert review from clinical and technical specialists to deliver validated, trustworthy recommendations. **Applications:** - Study Protocol Evaluation: Employs AI technologies to enhance the accuracy and efficiency of protocol assessments, identifying potential challenges or areas for improvement. - Clinical Feasibility Analysis: Provides critical insights into the practicality of proposed research projects, aiding in the decision-making process for medical product development. - AI-Enhanced Clinical Research: Supports the integration of AI tools to streamline clinical study planning and execution. **Who we are:** The **Fraunhofer IIS** has established the **"Center for Sensor Technology and Digital Medicine"** in cooperation with the University Hospital Erlangen and the University of Erlangen-Nuremberg to enhance healthcare efficiency through **sensors** and **digital solutions**. This center focuses on integrating **innovative medical technologies** like **patient-specific therapies**, **digital health applications**, **medical diagnostics** via **wearables**, and **robotic systems** for care. Located at the University Hospital Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Commissariat A L Energie Atomique Et Aux Energies Alternatives (CEA)

This service provides 2 types of analysis: - Ex vivo imaging study : Multiplex spatial distribution of molecular species in biological tissue - Profiling study: multiplex analysis in complex biological samples. It includes: - Project design & feasibility study - Sample conservation, preparation and analysis using softwares such as Fleximaging & Flexcontrol - Data analysis with provision of a final report Examples: Evaluate or Compare AI system of an IVD-MD to mass spectrometric (MALDI) data of specific animal/human tissue Keywords: Mass Spectrometry; MALDI; ex vivo imaging study; profiling study

Friedrich-Alexander-Universitaet Erlangen-Nuernberg (FAU)

Services: - Full body motion analysis using inertial motion capture, including posturography and pressure distribution - Video-based motion and facial expression analysis - Standardized and reliable gold standard stress induction - Collection of established biopsychological stress markers for further processing - Assessment and analysis of digital biomarkers during stress - Physiological measurements

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Stress test platform; sport, cardiovascular

Hospices Civils De Lyon (HCL)

Summative evaluation of finalized surgical robot prototype (design freeze) in order to validate usability (according to IEC 62366-1). This packaged service includes : - Operating room rental - Participants (healthcare professionals) recruitment within our hospital - Protocol elaboration - User testing organization and moderation - Analysis of collected data from a human factors perspective - Evaluation report including root causes analysis of errors, close calls and use difficulties observed Prices range is indicative and depends on testing protocol complexity and particpants number

Univerzitna Nemocnica Martin (University Hospital Martin)

Testing service designed for medical devices, prototypes, and healthcare technologies. Conducted in clinical environments to ensure devices meet safety, functionality, and regulatory standards necessary for market launch. This service reduces risks and enhances usability, accelerating the device's integration into clinical workflows. Keywords: Medical device testing, clinical validation, regulatory compliance, usability evaluation, healthcare technology

Fondazione Istituto Italiano Di Tecnologia (IIT)

This service provides a complete testing setup for gait analysis, motion capture and IEC 10328 compliance for robotic exoskeletons and prostheses. It also provides support and recommendations about how to design and develop robotic rehabilitation systems compliant to IEC 60601-1 standard. Method Description: The service will perform an assessment of wearable robotics solutions (e.g. exoskeletons and prostheses) by using a combination of the following resources: VICON workstation with 12 cameras, sensorized treadmill, force platforms, surface electromyograph, metabolimeter. Method reference: Tests will be based on standards, most notably IEC 10328, when applicable. Otherwise, based on scientific methods for gait analysis. Keywords: robotics; healthcare robotics; prosthesis; orthosis; exoskeleton; testing setup.

Politecnico Di Milano (POLIMI)

This service offers the design of usability and clinical trials for the evaluation of exoskeleton both for the assistance of persons with disabilities and for the support of workers. The evaluation is based on a benchmarking scheme of upper limb functions capacity through a Motion Analysis Laboratory equipped with optoelectrontric systems or wearable inertial units, force platforms, surface electromyiograph, baropodometric platform. The service will be provided in collaboration with the clinical center "Villa Beretta" (Lecco). Keywords: Upper Limb Exoskeleton, Motion Analysis Laboratory, EMG, Benchmarking schemes, Design of Clinical Evaluation

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Service Keywords:** Expertise in Electrophysiological Signals, Cardiovascular Diseases, Multimodal Data Acquisition (ECG, EMG, EEG, EOG, EDA), Project Design, Clinical Study Design, Scientific-Technical Consulting, Data Evaluation, Data Acquisition, Technical Support, Performance Evaluation/Reporting **Equipment:** - Biosign HRV-Scanner Model II: Mobile blood pressure monitor for evaluating heart rate variability. - SomnoMedics Sleep Monitor: Measures EEG, ECG, BP, oximetry, IMU, and EMG for comprehensive sleep assessments. - Biopac System: Monitors ECG, respiration, oximetry, EEG, EMG, and skin temperature for detailed physiological recordings. - Wireless Biopac System: Offers the same capabilities in a mobile format for versatile monitoring. - Vinno G55: Provides advanced ultrasonic imaging for cardiac and vascular assessments. - Maphera: A multimodal, portable, wireless biomedical acquisition system for a variety of physiological data. - Custo Guard Holter with Custo Wing: Long-term ECG monitoring for in-depth cardiac analysis. **Who Can Benefit:** - Cardiologists: For conducting advanced diagnostic assessments and managing patient care through detailed cardiac and electrophysiological data. - Biomedical Researchers: To explore cardiovascular physiology and develop innovative treatments or technologies. - Healthcare Engineers: For designing and testing medical devices that integrate with cardiovascular monitoring technologies. - Clinicians and Healthcare Institutions: To enhance clinical services and research capabilities with comprehensive cardiac assessment tools. **Key Features:** - Comprehensive Cardiac Monitoring: Equipped with advanced systems to evaluate a wide range of cardiovascular and electrophysiological parameters, ensuring precise and detailed analysis. - State-of-the-Art Technology: Utilizes cutting-edge equipment for both mobile and in-lab assessments, supporting diverse clinical and research applications. - Expert Support: Offers extensive scientific and technical consulting, with expertise in electrophysiological signals, to guide project design and enhance study outcomes through high-quality data recording and analysis. **Possible Applications:** - Clinical Trials: Facilitates rigorous evaluation of new cardiac therapies and devices, providing essential data for regulatory submission and clinical validation. - Patient Monitoring: Enables continuous monitoring of cardiac health, improving early detection and intervention for arrhythmias and other cardiovascular conditions. - Research and Development: Supports the development of novel diagnostic and therapeutic solutions by providing a robust platform for electrophysiological data acquisition. **Who We Are:** The **Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS)** has established the **"Center for Sensor Technology and Digital Medicine" (CEMDIS)** in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through **innovative sensor technology** and **digital solutions**. This center focuses on integrating **innovative medical technologies** such as **wearables** and **robotic systems** to support **medical diagnostics**, **patient monitoring** and **evaluating patient-specific therapies** by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Equipment:** - Gym Setup: Comprehensive facilities equipped for diverse sports and exercise testing. - Ergometer and Track: Standard equipment for controlled cardiovascular and endurance assessments. - BioPac System: Monitors ECG, respiration, oximetry, EEG, EMG, and skin temperature for thorough physiological analysis. - Wireless BioPac System: Offers mobile monitoring capabilities, ideal for field and in-lab scenarios. - Mobile ECG (Holter): Includes BTL Flexi 12, BTL Holter 08, and CardioSecure for continuous heart monitoring. - Smart Textiles: Integrates ECG and respiration monitoring directly into sportswear for seamless data collection. - XSens Cameras and Systems: Advanced biomechanical sensing with MVN Link, MVN Awinda 2, and pressure mapping for comprehensive motion capture and analysis. **Who Can Benefit:** - Sports Scientists and Researchers: For conducting advanced studies on human movement and optimizing athletic performance. - Athletic Trainers and Coaches: To design and refine training strategies based on precise biomechanical and physiological data. - Physical Therapists: To develop tailored rehabilitation programs and track recovery using comprehensive performance assessments. - Biomechanical Engineers: For developing sports-related technologies and equipment by leveraging biomechanical insights. - Professional and Amateur Athletes: To enhance performance and reduce the risk of injuries through data-driven insights. **Key Features:** - Multimodal Physical Activity Analysis: Specializes in comprehensive assessments of athletic performance using a wide range of physiological and biomechanical measurements. - State-of-the-Art Equipment: Provides versatile setups and advanced monitoring technologies to capture detailed data on physical activity and sports performance. - Expert Support: Offers robust scientific and technical consulting, featuring expertise in both electrophysiological signals and biomechanics, to optimize study design and data analysis. **Possible Applications:** - Athletic Performance Testing: Facilitates detailed analysis of athletes' physical abilities and limitations, supporting personalized training and rehabilitation programs. - Sports Science Research: Enables the study of biomechanics and physiology in sports settings, contributing to the development of innovative training methods and performance-enhancing techniques. - Injury Prevention and Rehabilitation: Assists in identifying risk factors and monitoring recovery progress, helping to minimize injury occurrence and expedite rehabilitation. - Neurological Disease Assessment: Identifying the severity of a Parkinsons disease from the gait of the patient. **Who We Are:** The **Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS)** has established the **"Center for Sensor Technology and Digital Medicine" (CEMDIS)** in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through **innovative sensor technology** and **digital solutions**. This center focuses on integrating **innovative medical technologies** such as **wearables** and **robotic systems** to support **medical diagnostics**, **patient monitoring** and **evaluating patient-specific therapies** by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Fondazione Istituto Italiano Di Tecnologia (IIT)

This service provides a physical space (a multisensorial laboratory) that supports the testing and fast prototyping of multi-modal models deployments (images, text, other medical data) at different stages (dataset preparation, training, testing and evaluation). Such physical infrastructure provides a testing backbone to support small-scale proof of concept of large scale artificial intelligent architectures including the support from HPC infrastructures. Method Description: The service support SMEs in deploying multi-modal AI models related to their specific application scenario offering a physical intelligent environment that facilitates early prototyping and controlled testing . Method reference: Based on several state of the art architecture: Transformers, Diffusion Models, U-nets, and the most popular deep learning architectures.

Karolinska Institutet (KI)

The Unit: Clinical Genomics Stockholm (https://www.scilifelab.se/units/clinical-genomics-stockholm/) This infrastructure is part of Science for Life Laboratory (SciLifeLab) which is an academic collaboration between Swedish universities (including Karolinska Institutet) and a national research infrastructure with a focus on life science. Clinical Genomics Stockholm unit is a research infrastructure for large-scale, genomics-based analyses using next generation sequencing technologies. The unit assists in translational research projects, in the translation of genomics-based tools to routine clinical care and also aims to improve the capability for national microbial surveillance and for pandemic preparedness. The Service: Transcriptome sequencing (RNA-seq) Sequencing of mRNA (poly A based method) followed by fusion detection or germline analysis. This service encompasses: o Consultation (Project design, Target capture design) o Sample management o RNA sequencing (total RNA, mRNA) o Bioinformatics (Bioinformatic analysis on data generated at CG) Equipment Our unit has access to specialized equipment that enable us to factilitate the translation of new high-throughput techniques into clinical use. These include, but are not restricted to: • Various automatic robotic systems (BRAVO NGS Workstation, Hamilton NGS Star) • Various systems for QC, quantification and fragment analyses (TapeStation, Quantification using fluorescent assay (Qubit, Quantit)) • Instrumentation for real time PCR and ddPCR (BioRad qPCR) • Instrumentation for Multispectral imaging (Saphyr optical mapper) • Sequencing platforms: o Illumina (NovaSeq 6000, NovaSeq 6000 Dx, NovaSeq X) o Nanopore (PromethION “access via NGI”) o PacBio (Revio)

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Formative evaluation of medical devices: user testing of any medical device prototype in order to improve usability (according to IEC 62366-1). It includes: - writing protocols depending user profiles. - recruitment of required healthcare professionals and patients - rental of the operating room if needed - rental of phantoms - one or several iterative user testing steps and result analyses - evaluation report including ergonomic corrections and guidelines to bring to the medical device

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Summative evaluation of medical devices: final user testing of any medical device in order to carry out the final summative evaluation needed for CE mark (according to IEC 62366-1). It includes: - writing the protocol - recruitment of required healthcare professionals and patients - rental of the operating room if needed - rental of phantoms - user testing according the defined protocol and result analyses - evaluation report.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

User interface evaluation is conducted with the intent to explore user interface design strengths, weaknesses, and unanticipated use errors. The usability testing focuses on the user experience with the device, including the device's graphical user interface (GUI). While a formative usability test goal is to identify and correct any usability problems before the device design is finalized, a summative usability testing intends to generate evidence that a final product that is not only functional but also intuitive and enjoyable to use, leading to increased user satisfaction and loyalty. IPN is able to provide support in a two-step approach: • Study Documents & Submission Process, supporting the preparation of the mandatory documents and the submission of study to the Regulatory Authorities (ethics committees); • Study Conduction & Data Management, supporting the Site Initiation activities, recruitment process, data collection/analysis according to good clinical practices and report

CEED - Charité Healthcare Services GmbH

Our usability and user experience (UX) tests enable the evaluation of prototypes during the conceptual phase (formative evaluations according to IEC 62366) as well as existing products in collaboration with clinical users. The tests include a detailed analysis of user interaction to assess effectiveness, efficiency, and satisfaction during use. They can be conducted either in immersive simulation settings at the new BeST simulation center or in real clinical environments at Charité hospitals, depending on specific needs and requirements. Keywords: Usability Testing, Usability, Usability Engineering, User Satisfaction and Acceptance, Formative Evaluations, Prototype Testing, User Recruitment, Development of Test Procedures, Execution and Evaluation according to IEC 62366, Realistic Testing Environment

CEED - Charité Healthcare Services GmbH

Our usability validation/summative evaluation offer includes the final assessment of the usability of medical devices according to the requirements of IEC 62366. Depending on the needs, we provide comprehensive consulting for the design of the summative evaluation and take care of planning, recruiting users, as well as conducting and analyzing the tests. Summative evaluations can be conducted either in immersive simulation settings at the new BeST simulation center or in real clinical environments at Charité hospitals. Keywords: Usability Validation, Summative Evaluation, Usability Engineering, User Recruitment, Development of Test Procedures, Execution and Evaluation according to IEC 62366, Realistic Testing Environment

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

IPN team is able to support the companies planning the iterative process where usability tests are carried out, finding the users and the usability scenario(s)/environment(s) and, if needed, the clinical researchers to conduct the testing in order to ensure that the solution usability is designed so that use-related risks are decreased, and safety increased.

Univerzitna Nemocnica Martin (University Hospital Martin)

The Wearable Devices Lab focuses on testing medical devices, prototypes, and healthcare technologies in clinical settings. It evaluates functionality, safety, and usability under real-world conditions to ensure devices comply with regulatory standards and are prepared for market introduction. Keywords: wearable devices, clinical testing, regulatory compliance, usability assessment

Karolinska Institutet (KI)

The Unit: Clinical Genomics Stockholm (https://www.scilifelab.se/units/clinical-genomics-stockholm/) This infrastructure is part of Science for Life Laboratory (SciLifeLab) which is an academic collaboration between Swedish universities (including Karolinska Institutet) and a national research infrastructure with a focus on life science. Clinical Genomics Stockholm unit is a research infrastructure for large-scale, genomics-based analyses using next generation sequencing technologies. The unit assists in translational research projects, in the translation of genomics-based tools to routine clinical care and also aims to improve the capability for national microbial surveillance and for pandemic preparedness. The Service: Whole genome or targeted DNA sequencing Sequencing of the entire human genome (with a PCR-free protocol) or selected parts of the genome (through exome or panel sequencing), followed by germline or somatic analysis. This service encompasses: o Consultation (Project design, Target capture design) o Sample management o DNA sequencing (Whole Genome Seq (WGS), Whole Exome Seq (WES), Panels) o Bioinformatics (Bioinformatic analysis (data generated at CG) Equipment: Our unit has access to specialized equipment that enable us to factilitate the translation of new high-throughput techniques into clinical use. These include, but are not restricted to: • Various automatic robotic systems (BRAVO NGS Workstation, Hamilton NGS Star) • Various systems for QC, quantification and fragment analyses (TapeStation, Quantification using fluorescent assay (Qubit, Quantit)) • Instrumentation for real time PCR and ddPCR (BioRad qPCR) • Instrumentation for Multispectral imaging (Saphyr optical mapper) • Sequencing platforms: o Illumina (NovaSeq 6000, NovaSeq 6000 Dx, NovaSeq X) o Nanopore (PromethION “access via NGI”) o PacBio (Revio) Prospective Use case: AI based software solution uses WGS data to identify genetic biomarkers to help clinicians either during diagnostic phase and/or at the treatment phase in order to identify genetic aberrations possibly explaining the disease onset or to assist in the therapeutic decisions such as for example in breast cancer the presence of BRCA1 mutation. AI software can be trained to learn to deliver diagnostic based on WGS data (especially needed in the field of rare diseases) to recognize genetic variations (from single nucleotide to over 50bp deletion or insertion) in a more robust and accurate manner (to limit generation of false negative or false positive cases) to support clinicians in their decision process.