Consulting services

Politecnico Di Milano (POLIMI)

Providing expertise in the field of medical robotics (medical imaging for surgical planning, virtual reality, extended reality) to be eventually tailored to specific projects: 1) Definition of applications objectives 2) Data collection, data curation and bias evaluation 3) Preprocessing and optimization of feature extractions 4) Selection of suitable machine learning models, model training and testing 5) External validation 6) Interpretations of models (XAI algorithm applications and development) Keywords: AI, algorithm development, AI testing and validation, Medical Imaging for Surgical Planning, Virtual Reality, Extended Reality

Fondazione Bruno Kessler (FBK)

This service covers all key aspects of development and deployment of AI solutions, based on shallow machine learning or deep learning). State-of-the-art pipelines are generated/improved leveraging on various technonolgies or solutions such as: data encoding, management of missing data, data augmentation and syntetic data generation, model selection and optimisation, hyperparameters tuning, fine-tuning, data shift and transfer learning, reproducibility and explainability. Keywords: Biomedical data Analysis, Deep Learning, CNN, Machine Learning, Image Analysis, Synthetic Data Generation

Multitel (MULTITEL)

Design, Optimization and Small Series Production of Prototypes: The MULTITEL team excels in creating bespoke prototypes and limited series, demonstrating the potential of AI and optoelectronics applications in various domains.

Vlaamse Instelling Voor Technologisch Onderzoek N.V. (VITO)

Evaluation of medical AI using real-world Data and Synthetic Data to create a strong technical AI evaluation report. Method: evaluation of medical AI products, taking into account the differences between subpopulations, sources of bias, metric selection, uncertainty intervals, among others. Keywords: AI performance evaluation, test report

Vlaamse Instelling Voor Technologisch Onderzoek N.V. (VITO)

Specialized training on how to thoroughly evaluate the performance of Medical AI models and create test reports for notified bodies. Medthod: Organisation of in-person and online training for Medical AI companies to enable them to create strong technical AI evaluation reports. Keywords: AI performance evaluation, test report, course

RISE Research Institutes Of Sweden

Method description: Develop and improve AI algorithms utilizing Deep Learning paradigms within Computer Vision, Data Analysis and Natural Language Processing. The service can include suggestions of applications and highlight strengths, weaknesses, or software development. The service is customized according to the SME's needs. Pre-requisites for the service are the analysis of data availability, data-readiness level and customer needs. Method reference: To be refined depending on the type of task, and in dialog with the customer. The Center for Applied AI at RISE carries out cutting-edge research in AI, connects expertise and applications within RISE, and explores a wide range of innovative applications with industry and the public sector. Applied AI Centre at RISE helps companies and government agencies to see more potential in the technology, use it more wisely and develop it faster. Keywords: Trustworthy AI, Federated learning, Data Science, AI, Deep Learning, Natural language processing, Computer Vision, Machine Learning

Multitel (MULTITEL)

Development and improvement of innovative AI solutions, tailored to the unique challenges and opportunities of the SME. From 1D, 2D, 3D data or multimodal data, MULTITEL develops and improves customized AI models, leveraging its expertise in AI, embedded systems, machine learning, optoelectronics and optics to deliver robust, efficient solutions. With a focus on refinement, MULTITEL also enhances the performance of existing AI models, ensuring they meet the latest standards in speed, accuracy, and functionality.

Zilinska Univerzita V Ziline (UNIZA)

Tailored development and consultation of AI models, including supervised, unsupervised, and reinforcement learning approaches. This service supports SMEs in designing, training, validating, and deploying AI solutions. Technical details:Python-based frameworks (TensorFlow, PyTorch), model hosting options. Use cases/examples:SME is looking for information on how to evaluate their model or how to design adequate architecture.

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Helping to rigorous testing and validation of the developed Multimodal AI models in real hospital environments based on real-world medical images and with collaboration with AI experts and medical staff. In collaboration with the medical staff and advanced deep learning algorithms, test the AI models on datasets not yet seen by the AI to confirm the correct behaviour of the AI. Discussion with medical experts and validation with new data sets (continuous learning) to ensure that the AI is still correct even with new data). Verification that there are no biases. Keywords: Medical Image Analysis; Deep Learning Algorithms; Binary Classification; Anomaly Localization; AI Model Development; Real-World Images; AI Testing and Validation; Collaboration with Medical Staff; AI Expertise; Custom Pretrained Pipelines; Clinical Imaging; Image Segmentation; Image Feature Extraction; Trustworthy AI

Vlaamse Instelling Voor Technologisch Onderzoek N.V. (VITO)

Semi-automated performance monitoring of the Medical AI deployed in the clinical practice, following PMS regulation. Making the distinction between deployments where good model performance can be guaranteed and where not. Consultancy services on automated model performance monitoring in the clinical practice, in compliance with Medical Device Regulation (MDR). Keywords: AI performance evaluation, performance monitoring, PMS, PMCF

RISE Research Institutes Of Sweden

Method description: Investigate Data to be usable in an AI context. The service is customized according to the SME's needs. Method reference: To be refined depending on the type of task, and in dialog with the customer. The Center for Applied AI at RISE carries out cutting-edge research in AI, connects expertise and applications within RISE, and explores a wide range of innovative applications with industry and the public sector. Applied AI Centre at RISE helps companies and government agencies to see more potential in the technology, use it more wisely and develop it faster. Keywords: Trustworthy AI, Federated learning, Data Science, AI, Deep Learning, Natural language processing, Computer Vision, Machine learning.

RISE Research Institutes Of Sweden

Method description: Preprocessing Data to be AI-ready. This service can be a preprocessing step to perform other AI services from RISE, for example RISE's service "AI improvement and development". The service is customized according to the SME's needs. Method reference: To be refined depending on the type of task, and in dialog with the customer. The Center for Applied AI at RISE carries out cutting-edge research in AI, connects expertise and applications within RISE, and explores a wide range of innovative applications with industry and the public sector. Applied AI Centre at RISE helps companies and government agencies to see more potential in the technology, use it more wisely and develop it faster. Keywords: Trustworthy AI, Federated learning, Data Science, AI, Deep Learning, Natural language processing, Computer Vision, Machine Learning.

Multitel (MULTITEL)

Technology Watch and Guidance: MULTITEL keeps businesses at the forefront of AI advancements, offering insights and guidance in emerging technologies. Technical Tests and Feasibility Studies: MULTITEL rigorously tests and assess the practicality of AI solutions, ensuring they align with your business needs. Keywords: AI technical support

RISE Research Institutes Of Sweden

Method description: This service performs testing, evaluation and verification of AI systems in light of the EU AI-Act. Methods consists of traditional performance testing coupled with formal methods to prove safety and functionality requirements, if applicable. The requirements put on the models are formulated in collaboration with the customer. RISE performs the corresponding virtual tests and records the results in a test and verification report. Method reference: To be refined depending on the type of task, and in dialog with the customer. The Center for Applied AI at RISE carries out cutting-edge research in AI, connects expertise and applications within RISE, and explores a wide range of innovative applications with industry and the public sector. Applied AI Centre at RISE helps companies and government agencies to see more potential in the technology, use it more wisely and develop it faster. Keywords: AI systems, Data Science, Deep Learning, Natural language processing, Machine Learning, Trustworthy AI

Politecnico Di Milano (POLIMI)

Conceiving, developing and optimization of AI algorithmic approaches across the whole pathway: 1) Definition of applications objectives 2) Data collection, data curation and bias evaluation 3) Preprocessing and optimisation of feature extractions 4) Selection of suitable machine learning models, model training and testing 5) External validation 6) Interpretations of models (XAI algorithm applications and development). Keywords: AI, algorithm development, AI testing and validation, Data Curation, Feature Extraction, Learning Models, External Validation, XAI

Friedrich-Alexander-Universitaet Erlangen-Nuernberg (FAU)

AI-backed services around algorithm improvement are offered after individual consulting. We provide expertise in algorithm improvement for start-ups/SMEs based on their specific needs https://doi.org/10.1109/OJEMB.2024.3356791 Keywords: Algorithm, AI, data science, medical data, agile development

Berlin Simulation and Training Center (BeST)

Since 1996: Increase in treatment quality and patient safety through simulation-based 1. Advanced training and continuing education of all professions in the healthcare sector 2. Increase in effectiveness and efficiency of clinical processes 3. Agile research and development of medical systems. 1,600 m2 at new Charité building + Operating theaters, ICU, practices, living room, ward, transport…​ + Unkillable patients​: actors, mannequins, virtual reality, body donations, 3D prints, animals (at CVK)​ + Isolated network with on-demand Charité infrastructure and public cloud​ + Medical systems by many vendors​ + Access to co-incentivized Charité healthcare professionals​ - Modelling and tangibility of patient journeys​ - Workflow Implementability - Consensus facilitation​ - IT Integrability​ - Change Management​ - CoCreation and CoDevelopment​ - Boundary condition homogenization​ - Value Proposition Validation & Demonstration​

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

Assisting companies on how to utilize extended reality technologies within their company. Either with their current services and products,with new products or for training and orientation.

Politecnico Di Milano (POLIMI)

This service offers biostatistical consulting relevant to Data Analysis to be obtained through the clinical evaluation procedure and relevant statistical evaluation; Application of MDCG 2020-1 principles in the design of the specific clinical study. Keywords: Clinical investigation, clinical study, clinical evaluation procedure, statistical analysis;

Univerzitna Nemocnica Martin (University Hospital Martin)

Service helps the client company to build a sustainable model that can adapt and grow in a competitive market by focusing on several key components: - Market Research and Analysis: Understanding the market landscape, identifying trends, evaluating competitor business models, defining and segmenting the target customers based on their demographics, behaviours, and needs, identifying their pain points and unmet needs to ensure the business model addresses real customer challenges. - Value Proposition Design: defining the unique value the company offers, focusing on solving customer problems or delivering specific benefits, how the business’s offering stands out from competitors - Revenue Model and Pricing Strategy: exploring sources of revenue, designing a pricing model that reflects the value delivered and aligns with customer willingness to pay. - Key Resources and Activities: determining the essential resources (human, financial, physical, and intellectual) and activities required to execute the business model. - Key Partnerships and Networks: identifying partners who can enhance value, such as suppliers, distributors, or technology providers. - Channel Strategy: determining the optimal channels for promotion and engagement, as well as selling to customers - Costs and Revenue: developing basic cash flow model - Performance Metrics: establishing key performance indicators (KPIs) to measure success Key words: Business consulting, Business development, Business model

Health Cluster Portugal - Associacao Do Polo De Competitividade Da Saude (HCP)

Consulting support related to all aspects of business model development. Keywords: Business Analysis, business plan, market

CEED - Charité Healthcare Services GmbH

We develop customized processes, SOPs, and templates tailored precisely to your regulatory requirements.With our clinic-oriented support for generating clinical data, we offer comprehensive assistance with data collection and analysis, as well as access to relevant resources, such as through our university hospital Charité - Universitätsmedizin Berlin. We also assist you in utilizing Real-World Data to collect and evaluate practical data. Furthermore, we conduct literature and database searches to efficiently gather and analyze the necessary information for your clinical studies and clinical evaluations. Keywords: Clinical Data, Data Collection, Data Analysis, Charité - Universitätsmedizin Berlin, Literature Review, Database Research, Data, Real-World Data, RWD, Real-World Evidence, RWE

Univerzitna Nemocnica Martin (University Hospital Martin)

This service provides clinical testing and evaluation of medical device prototypes or healthcare technology solutions in real-world settings. It assesses functionality, safety, usability, and performance under clinical conditions, gathering essential data for further development and regulatory approval. Clinical evaluations are conducted on-site in healthcare environments by trained teams who manage setup, monitoring, and assessment according to standardized protocols, offering detailed reports on clinical performance, usability, and safety. Keywords: prototypes, real-world testing, medical device prototypes, testing

CEED - Charité Healthcare Services GmbH

Our support for conducting the clinical evaluation of medical devices includes comprehensive planning and concept development for your specific clinical evaluation. We develop customized processes, SOPs, and templates tailored precisely to your regulatory requirements. We take care of the creation and continuous updating of the necessary documents, such as the Clinical Evaluation Plan (CEP) and the Clinical Evaluation Report (CER), to ensure that your clinical evaluation meets the highest standards. Keywords: Clinical Evaluation, Clinical Evaluation Plan, CEP, Clinical Evaluation Report, CER, Charité - Universitätsmedizin Berlin

CEED - Charité Healthcare Services GmbH

Our Clinical Needs Analyses focus on examining specific requirements and needs within the clinic. This can include evaluating processes, workflows, or medical equipment to derive measures and product ideas that improve the efficiency, effectiveness, and quality of patient care, as well as the working conditions of clinical staff. The analyses enable products to be tailored to the specific needs and requirements of the clinic, fostering market-oriented innovations and enhancing efficiency and customer retention. Our Medical Needs Analyses focus on investigating requirements and needs in healthcare, including assessing the current state of research and technology. The analyses provide insights into the prevention, diagnosis, and treatment of diseases, as well as trends and challenges. They serve as a foundation for developing new products and services that meet or exceed current medical standards and support targeted innovation and effective resource utilization. Keywords: Clinical Expertise, Clinical Requirements, Medical Requirements, State of the Art, Market Needs, Literature Research, Interviews, Workshops, Workplace Analyses

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Support SME to define the clinical investigation methodology (number of subjects, study design, endpoints definition, among others) and to write a first synopsis. It may include: Identification & access to medical & other experts advice; Support to get funding research. Keywords: Clinical investigation, clinical study, methodology, synopsis, funding

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Support SME to define the clinical investigation methodology (number of subjects, study design, endpoints definition, among others) and to write a first synopsis. It may include: - Access to expert medical opinion. - Budget proposal for the clinical investigation. - Support to funding research; Keywords: Clinical investigation, clinical study;

Univerzitna Nemocnica Martin (University Hospital Martin)

The Clinical Study Center offers comprehensive support for the design, implementation, and management of clinical trials. This service focuses on ensuring the integrity, quality, and compliance of clinical studies across various medical fields. The center provides expert guidance on protocol development, regulatory submissions, site management, and data collection, ensuring that all trials meet regulatory standards and are conducted ethically. With a dedicated team of experienced professionals, the center facilitates patient recruitment and retention, monitors trial progress, and ensures accurate data reporting.

Centre Hospitalier Universitaire De Grenoble (CHUGA)

This service includes first meetings with experts in clinical investigation to support the SME in the maturation process of its innovative medical device and define the main steps in the clinical study process depending the SME needs. Access to expert medical opinion. Support to funding research; Keywords: Clinical investigation, clinical study;

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

This service includes first meetings with experts in clinical investigation to help the SME in the maturation process of its innovative medical device and define the main steps in the clinical study process depending the SME needs. Definition of the SME needs; Confirmation of the product maturity level; Identification & access to medical & other experts advice, inner partners & external providers; Support to estimate funding research. Keywords: Clinical investigation, clinical study, feasibility, expertise, maturity, TRL

Politecnico Di Milano (POLIMI)

Consulting on the design of a clinical protocol for the clinical evaluation procedure to collect clinical data in support to the certification process throughout the lifecycle of the medical device. Application of MDCG 2020-1 principles in the design of the specif clinical study; MDCG 2020-1. Keywords: Clinical investigation, clinical study, clinical evaluation procedure, CE certification process

Istituto Giannina Gaslini (IGG)

Our service can provide consulting for designing Clinical Trials in a realistic pediatric environment; Ethical commettee documentation; Pediatric environment; Clinical trial roadmap; Statistics; best trial type determination. Prices are subject to change and are only indicative. The final price will be determined in the contract between the service provider and the applicant.

Istituto Giannina Gaslini (IGG)

Consulting for designing Clinical Trials in a realistic pediatric environment. Keywords: Ethical commettee documentation; Pediatric environment; Clinical trial roadmap; Statistics; best trial type determination;

Univerzitna Nemocnica Martin (University Hospital Martin)

Description of sequence and structure of particular activities of a clinical trial (CT). Selection of a suitable trial design and identification of alternative clinical trial designs and implementation issues. Service includes: Initial Consultation with CT Coordinator: planning of details of a trial such as endpoints and outcomes, sample size calculations, data management, study protocol, randomization, patient and site recruitment, funding, insurance, etc. CT Protocol: elaborating CT protocol for the Investigator (client company! Including necessary documentation kit for CT running (inform consent, donation agreement, etc.) CT Registration: submitting CT protocol to respective authorization body and in Clinical Trials Information System Key words: Clinical trial design, Clinical protocol, Clinical testing, Investigation, Research

Politecnico Di Milano (POLIMI)

Comparative study of competing products in the market of rehabilitation robotics. Support testing protocol design with healthy, elderly and post-stroke subjects and comparison with benchmarking. For Upper Limb robotics see paper DOI 10.1186/s12984-022-01082-8. Keywords: Comparative study, Market Analysis, Healthcare Robotics, Upper Limb

Health Cluster Portugal - Associacao Do Polo De Competitividade Da Saude (HCP)

Benchmarking analysis reports to help SMEs assess their position in relation to global competitors. Keywords: Competitors; Market; Business

Technische Universitaet Muenchen (TUM)

Consulting activities to enable usage by customers of a virtual testing and experimentation facility for robotic simulation, with a view to achieve one of more of the following outcomes: in silico training and optimization (e.g., reinforcement learning, genetic algorithms, etc.), performance evaluation of AI-based controllers for robotics in virtual testing environment, or definition and implementation of testing & benchmarking scenarios on specific simulators (e.g., Unity, PyBullet, MuJoCo, etc.). Keywords: Robotics; Simulation of modular heterogeneous systems; In silico functional evaluation of algorithms and AI models for robotics; Optimization of algorithms and AI models for robotics

Laboratoire National De Metrologie Et D'Essais (LNE)

Study and assess the development and evaluation process used by the SME/startup in the development of an AI system. The service consists of an assessment of the development process and evaluation of the AI systems. The consulting service method is based on the study of the documentation describing the process and meetings with the AI team. Keywords: Process assessment, process improvement, data qualification, documentation, transparency, tracability, evaluation

Zilinska Univerzita V Ziline (UNIZA)

Development of intelligent, conversational chatbots powered by large language models (LLMs), tailored to specific healthcare, research, or business needs. These chatbots can understand and generate natural language responses, integrate with organizational knowledge bases, and support advanced tasks such as appointment scheduling, information retrieval, or interactive education. Technical details:Python, LLMs, custom datasets. Use cases/examples: SME wants to develop a chatbot service that would help users operate with their AI system.

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Providing prebuilt AI pipelines tailored for medical image analysis. Streamlining AI model integration into existing healthcare workflows. Accelerating the deployment of AI solutions in clinical settings. Using MLOps and DVC to accelerate the AI development and deployment with CI-CD pipelines. Keywords: Medical Image Analysis; Deep Learning Algorithms; Binary Classification; Anomaly Localization; AI Model Development; Real-World Images; AI Testing and Validation; Collaboration with Medical Staff; AI Expertise; Custom Pretrained Pipelines; Clinical Imaging; Image Segmentation; Image Feature Extraction; Trustworthy AI

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Consolidate a (multicentric) medical database including medical imaging and patient records. Assess the quality control of the medical database regarding data and GDPR requirements; Classification and categorization of the data regarding medical biases Keywords: Data, AI, regulatory, preclinical and clinical testing, surgery

RISE Research Institutes Of Sweden

Method description: Integration of data from different datasets. Not exclusively, however this service can be performed as a data preprocessing step to "AI improvement and development" service available from RISE. The service is customized according to the SME's needs. Add-on service to other services. Method reference: To be refined depending on the type of task, and in dialog with the customer. The Center for Applied AI at RISE carries out cutting-edge research in AI, connects expertise and applications within RISE, and explores a wide range of innovative applications with industry and the public sector. Applied AI Centre at RISE helps companies and government agencies to see more potential in the technology, use it more wisely and develop it faster. Keywords: Trustworthy AI, Federated learning, Data Science, AI, Deep Learning, Natural language processing, Computer Vision, Machine Learning.

RISE Research Institutes Of Sweden

Method description: Analysis of big datasets. Not exclusively, however this service can be performed as a data preprocessing step to "AI improvement and development" service available from RISE. The service is customized according to the SME's needs. Add-on service to other services. Method reference: To be refined depending on the type of task, and in dialog with the customer. The Center for Applied AI at RISE carries out cutting-edge research in AI, connects expertise and applications within RISE, and explores a wide range of innovative applications with industry and the public sector. Applied AI Centre at RISE helps companies and government agencies to see more potential in the technology, use it more wisely and develop it faster. Keywords: Trustworthy AI, Federated learning, Data Science, AI, Deep Learning, Natural language processing, Computer Vision, Machine learning.

Fondazione Bruno Kessler (FBK)

This service covers all aspects regarding the analysis of data useful to understand the task, including problem identification, data curation and preprocessing, statistical and exploratory data analysis, interpretation and visualization. Keywords: Biomedical data Analysis, Data Processing, Data Science.

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Consolidate database through curation and data analysing. Keywords: Data, AI, preclinical and clinical testing, surgery

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Combinatorial optimization solution for processes, scheduling and logistics optimization. Provide expertise on how to address large scale routing, scheduling, logistics and other combinatorial optimisation problems using constraint-based local search. Keywords: Resource Planning, Patient Transportation, Process Optimasation

Health Cluster Portugal - Associacao Do Polo De Competitividade Da Saude (HCP)

This service offers a comprehensive overview of the medical device market, including insights into product pipelines and category rankings on a global scale. Keywords: Medical Device; Market; Analysis

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Challenge : The client may request from a software solution provider that a copy of the source code be held by a neutral third party. In the case of AI solutions, training data may also be involved. Security and confidentiality are obviously important. Our strength : CETIC routinely offers a secure procedure for retaining the source code of software and can extend this to AI-based software by managing and preserving the datasets used, thus demonstrating the ability to reproduce the protected software. This service enables a procedure to be put in place to preserve the source code of AI-based software by a trusted third party. This service will manage and preserve the datasets used to develop AI models. Keywords: Software Escrow services

Politecnico Di Milano (POLIMI)

Support in the functional evaluation of Human-Robot Interface (motion capture, EMG, EEG, etc) Costs estimation for both prototype development and volume manufacturing to support SMEs/start-up plan and budgeting throughout the product development lifecycle. Keywords: Cost estimation, Prototype development, Volume Manifacturing, Budget Planning, Manufacturing Costs, Product Development Lifecycle, Cost Optimization;

HUMANI SC - Hospital network (HUMANI)

Access to clinical and data experts to identify dataset needs.

CEED - Charité Healthcare Services GmbH

Our expert panels and workshops bring together professionals from various clinical areas to provide valuable insights and expertise during early concept, planning, design, and development phases. This collaboration allows for discussions of product ideas, evaluation of technical details and design aspects, identification of potential challenges, and development of innovative solutions that meet the needs of users and patients while adhering to the highest standards. Keywords:Expert Panels, Group Discussions, Clinical Expertise, Requirements Analysis, Workshops, User and Clinical Requirements, Requirements Engineering, Usability Engineering

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

Helping companies to evaluate and test extended reality technologies before investing in them. Assisting them in creating new ideas on how to utilize the technologies in their selected field.

RISE Research Institutes Of Sweden

Federated Learning (FL) is a transformative approach to Artificial Intelligence that allows models to learn from data without that data ever leaving its original location. In the healthcare sector, where patient privacy and data security are paramount, this service enables organizations to collaborate and train powerful AI models across multiple hospitals or clinics while keeping sensitive records safely behind their own firewalls. This service provides a comprehensive framework for designing, prototyping, and implementing distributed AI solutions. Many high-impact healthcare applications are currently stalled because moving data to a central server is either technically impossible due to bandwidth or legally restricted by GDPR and the AI Act. Our service bridges this gap by bringing the "learning" to the data. Technical Note: Federated Learning is used exclusively during the training phase. Once training is complete, the resulting AI model is a standard, standalone tool that can be deployed and used at any location at any time, identically to a traditionally trained model. We work closely with you to investigate the feasibility of federated learning for your specific datasets, ensuring that the resulting AI models are both high-performing and privacy-compliant. As this service is closely linked to our Privacy-Preserving Methods and Implementation offering, we integrate advanced techniques such as differential privacy or secure multi-party computation to ensure that even the model updates themselves do not leak sensitive information. How can the service help you? • Unlock Siloed Data: Train AI on distributed datasets that cannot be moved or merged due to legal (GDPR) or technical constraints. • Enhance Privacy: Minimize data exposure by keeping raw patient records on-premises. • Collaborative Innovation: Enable multiple SMEs or healthcare providers to co-develop a robust "Global Model" that performs better than any "Local Model" trained in isolation. • Regulatory Compliance: Align your AI development with the strict requirements of the AI Act and healthcare data regulations. How the service will be delivered Logistics: The service is delivered through the RISE Applied AI Center and can utilize the V-Platform (a Trusted Research Environment). It can be configured for on-site deployment within your infrastructure or via a cloud-federated setup. Delivery period: Engagements are planned in phases, starting with a feasibility study and moving into prototyping and implementation. Duration: Typically ranges from 3 to 6 months, depending on the complexity of the data architecture and the AI model requirements. Customer requirement: The customer must provide access to relevant use cases, problem statements, and data documentation. While raw data stays with the customer, technical access for the "FL-client" software is required. Deliveries: Prototyping of the FL architecture, integration of privacy-preserving hooks, and technical documentation. Output: A functional federated learning pipeline and a refined AI model optimized for distributed environments. This service is highly modular and can be customized to match your specific industry standards, technical infrastructure, and the specific sensitivity level of your health data.

Zilinska Univerzita V Ziline (UNIZA)

Provision of high-performance computing infrastructure powered by NVIDIA GPUs, enabling SMEs and researchers to train and test AI models in a scalable and secure environment. This service supports deep learning, computer vision, and large dataset processing tasks. Technical details:NVIDIA GPUs, remote access, Docker support, secured environment. Use cases/examples: SMEs without adequate training machines can rent full power of the high-end computers. The computer operates a platform for data storage, model training and evaluation.

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

As a non-profit and accredited centre, our experts provide a neutral and independent technical advice and support along the design and implmentation process. Service includes SotA (State of the Art) analysis and positioning, coaching on design choices, studying of alternatives for solutions involving embedded systems, elaborating design reviews, software and hardware architecture reviews, components selection, recommandations, analysis, etc. Keywords: SotA, design review, technical advice, independent expertise

Politecnico Di Milano (POLIMI)

Providing expertise in the field of medical robotics (exoskeletons and surgical robotics), to be eventually tailored to specific projects: 1) Definition of applications objectives 2) Support to the mechanical design of the robotics, mechanical design and embedded sensors 3) Firmware integration and software control 4) Technical, dry and experimental validation Keywords: Robotics Control, Robotics Design, Exoskeleton, Surgical Robot

Univerzitna Nemocnica Martin (University Hospital Martin)

Service suitable for middle and large client organizations striving to build functioning innovation ecosystem. It consists of three interconnected parts: - Assessment of Current State: evaluating current innovation culture, key stakeholders, talents, projects, idea pipelines, processes, partnerships, documentation, infrastructure (including IT), funding & investments and digitalization maturity within client organization. - Developing Roadmap for Future: elaborating simple and understandable path to improve current “status quo” within organization innovation management. Included will be “quick wins” - small, easy-to-implement measures that bring immediate positive results. - Interim Innovation Management: additional optional support to client organization management board. Based on developed roadmap in previous step delivering individual works to establish functional innovation management within client organization for short-term period (up to 6 months). Key words: Innovation, Creative ideas, Spin-off/Startup, Innovation labs, Research & Development & Innovation management

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

Along the innovative product/solution development pathway relevant go-no-go decisions should be taken into account. To ensure the suitability of the design and/or the product/solution market receptiveness, critical milestones should be checked in early phases to anticipate the health technology optimal launch. By granting the product/solution a KOL validation, by clinical experts through a systematic assessment approach, in a timely manner, will reduce the risk of failing the next steps of the way. IPN, in collaboration with Coimbra University Hospital – Unidade de Saúde Local de Coimbra (ULS-C) and the synergies settled through the TEF-Health partnership, counts on the expertise of high-tier health clinical professionals to provide new technologies assessment in a 3-step way, 1. Preliminary evaluation: the KOL self-assesses the product/solution provided information, to evaluate its medical purpose assumptions? If it answers an unmet medical need? competitor(s) in the market? Strengths/weaknesses of the technology? etc. 2. Short meeting: a 1:1 one-hour meeting, where the KOL is briefed with a 10-15 mins. demonstration of the product/solution, followed by a discussion of the concerning queries. 3. Expert assessment report: a report is issued addressing insight on the raised hot topics, including suitability strengths, weaknesses, opportunities and threats analysis (SWOT) analysis and useful recommendations/ suggestions to be considered.

Univerzitna Nemocnica Martin (University Hospital Martin)

Service delivers to client company specialized legal services based on the organization or founder(s) needs. It consists of: - Legal Advisory in IP Protection: expert guidance on securing and managing intellectual property rights, including patents, trademarks, copyrights, and trade secrets. It helps businesses prevent unauthorized use and protect their innovations, brand identity, and creative assets from infringement. - IP protection application: submitting the IP protection application on the behalf of the client for particular IP on national or internation (European) level. - Legal advisory on legal form establishment: assists in selecting the appropriate business structure, such as LLC, corporation, or partnership, based on business goals and legal requirements. This guidance ensures compliance with regulations and optimizes tax, liability, and ownership considerations. - Legal form set up: manages the legal steps to formally register a business entity, such as preparing legal documents of incorporation, partnership agreements, or LLC documentation. It includes filing necessary paperwork with government authorities and setting up a compliant legal structure. - Advisory in ​​Obtaining CE Marking: helps businesses understand the requirements for CE marking, which signifies conformity with EU health, safety, and environmental protection standards. It guides companies through compliance documentation, testing, and the assessment process needed to sell products in the European Economic Area. - Obtaining CE Marking: involves the practical steps of testing, certification, and documentation to ensure a product meets EU regulatory standards and qualifies for CE marking. The service also includes coordination with notified bodies or relevant testing agencies to confirm compliance. - Cap Table“ Legal Advisory: provides guidance on managing ownership structure, equity distribution, and shareholder interests within a company. It includes advice on structuring investments, issuing shares, and planning for future financing rounds to ensure equity stability and alignment with business growth plans. Key words: Legal advisory, IP protection, CE mark, Company set up, Legal form, Ownership, Shares

CEED - Charité Healthcare Services GmbH

Our medical device advisor training is aimed at all employees of medical device manufacturers and trading companies who inform about medical devices and provide training on their use. The training delivers practical, product- and company-independent fundamental knowledge required for this role. It clearly outlines the rights, responsibilities, and obligations of medical device advisors and is supported by the legal requirements of the MPDG and MDR. It is suitable for both new professionals entering the field and for updating and refreshing existing knowledge. Keywords: Training Concept according to MPDG, Rights and Responsibilities of Medical Device Manufacturer Employees, Fundamental Knowledge, Clinical Insights, On-Site or Online

Health Cluster Portugal - Associacao Do Polo De Competitividade Da Saude (HCP)

This service provides access to a network of organizations within the Portuguese health ecosystem and offers support in identifying and connecting with specific partners critical to the development of innovative solutions. Keywords: networking, partnerships

CEED - Charité Healthcare Services GmbH

Our clinic-oriented Post-Market Clinical Follow-Up (PMCF) support offers you comprehensive assistance with the planning and development of your PMCF activities. We develop customized processes, SOPs, and templates for updating the clinical evaluation, precisely tailored to your regulatory requirements. Our service includes the creation of all necessary documents, including the PMCF Plan and Report. Additionally, we support you in conducting PMCF studies, registries, and surveys, particularly at the university hospital Charité. With our expertise, we ensure that your PMCF activities not only comply with regulatory requirements but also provide valuable data for the continuous monitoring and improvement of your medical devices. Keywords:Post-Market Clinical Follow-Up, PMCF, Clinical Evaluation Update, PMCF Plan, PMCF Report, PMCF Studies, Register, Surveys, Charité - Universitätsmedizin Berlin

Politecnico Di Milano (POLIMI)

To facilitate post-market surveillance implementation, as introduced by the MDR, this service offers pro-active information retrieval relevant to reported problems in medical devices by scanning and aggregating query results from official public databases of competent national authorities. Keywords: Post market surveillance, Risk analysis, Pro-active market vigilance, MDR, Field safety notice, PSUR

CEED - Charité Healthcare Services GmbH

Our Post-Market Surveillance (PMS) support offers comprehensive assistance with post-market monitoring, such as planning and developing your PMS activities. We develop customized processes, SOPs, and templates precisely tailored to your regulatory requirements. Additionally, we handle the creation and regular updating of important documents such as the PMS plan, PMS report, and Periodic Safety Update Report (PSUR). Keywords: Post-Market Surveillance, PMS, Post-Market, PMS activities, PMS plan, PMS report, Periodic Safety Update Report, PSUR, safety report, trend analysis, continuous surveillance, Charité - Universitätsmedizin Berlin

Politecnico Di Milano (POLIMI)

In order to contribute to pre-market evaluation for a certain new technology, risk assessment based on the search for reported problems for products of similar category already on the market will be provided by scanning and aggregating query results from official public databases of competent national authorities. In addition, relevant manufacturers information to determine the actual market share will be also provided. Keywords: Risk analysis, Pre-market evaluation, New technology

RISE Research Institutes Of Sweden

Method description: Privacy-preserving and Federated analysis of the solution adapted to the customer Data and use cases. The service is customized according to the SME's needs. Method reference: To be refined depending on the type of task, and in dialog with the customer. The Center for Applied AI at RISE carries out cutting-edge research in AI, connects expertise and applications within RISE, and explores a wide range of innovative applications with industry and the public sector. Applied AI Centre at RISE helps companies and government agencies to see more potential in the technology, use it more wisely and develop it faster. Keywords: Trustworthy AI, Federated learning, Data Science, AI, Deep Learning, Natural language processing, Computer Vision, Machine Learning.

Univerzitna Nemocnica Martin (University Hospital Martin)

Testing assumptions about a product and its target market to ensure there’s demand and that the product meets customer needs. Within the service client can choose from individual testing option or their combination: - Customer Interviews and Surveys: talking to potential customers to gain qualitative insights into their needs, pain points, and buying criteria and/or sending surveys to gather data on a broader scale. - Testing Minimum Viable Product (MVP) with Early Adopters: offering the MVP to group of customers who like to try new products and collect feedback on product usability, satisfaction, and willingness to pay. - Analysing Market Demand through Landing Pages or Pre-Sales: setting up a simple landing page describing the product and its benefits with a call-to-action, such as signing up or pre-ordering. Using online advertising to drive traffic to the landing page and measuring the conversion rate of sign-ups or pre-orders. - A/B Testing: running A/B tests - experiment with different versions of client MVP, landing page, or pricing to see which elements resonate best with the target audience. Key words: Business consulting, Product testing, Market analysis, Market validation, Customer feedback

Politecnico Di Milano (POLIMI)

We offer a methodological approach to support SMEs/start-ups in the early development stages of a surgical robotic solution. We provide expertise in methodological approaches in the field of medical robotics. https://journals.sagepub.com/doi/full/10.1177/1729881419865805 Keywords: Requirement Elicitation Studies, Medical Robotics

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Development of PoCs (Proof of Concepts) or demonstrators involving data collection from distributed and heterogeneous data sources (IoT sensors, devices, APIs, etc.) based on lightweight but yet flexible and evolvable middleware architecture leveraging data modeling and data semantics. This service is customised to the customer need and PoCs can cover one, part or all of the following : IoT (wireless) protocols interfacing, gateway integration and programming, implementation of data processing, transformation and transmission to remote platforms. PoCs leverage DMWay toolbox where relevant ( https://asset.cetic.be/en/dmway/) Keywords: IoT, medical devices, wireless communication,firmware, middleware, PoC , prototype, gateway

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Assessment of the architectural quality of AI software. The service offers a high-level assessment of the quality factors in AI-based software architecture, from design to implementation, using CETIC's "Archicheck" methodology. The assessment is based on ISO25000 and provides scores for each criterion, as well as an overall score for architectural design quality. The assessment offers a quick, high-level overview of the quality of an application's architecture and pragmatic recommendations for rapidly improving problem areas. Keywords: quality development

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

Biological evaluation is a critical process in the development of medical devices, aimed at assessing their safety and biocompatibility when interacting with biological systems. This evaluation ensures that the materials used do not cause adverse biological responses, and is guided by the ISO 10993 family of standards. To systematically address these requirements, it is essential to develop a Biological Evaluation Plan (BEP), detailing the specific tests and assessments needed based on the device’s intended use, material composition, and duration of contact with the body. The findings from this process are compiled into a Biological Evaluation Report (BER), which summarizes the results, demonstrates compliance with ISO 10993, and ensures the device’s safety and regulatory approval.

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

Compliance with MDR requires a robust Clinical Evaluation to demonstrate the safety, performance, and clinical benefits of a medical device. This process involves a systematic assessment of clinical data related to the device. In the context of Clinical Evaluation, IPN services include: - Development of a Clinical Evaluation Plan (CEP): Defining the scope, methodology, and objectives of the evaluation, tailored to the device and its intended use. - Identification and Appraisal of Clinical Data: Systematic collection, appraisal, and analysis of clinical data from existing literature, clinical investigations, and post-market sources. - Elaboration of the Clinical Evaluation Report (CER): Compilation of all findings into a detailed CER aligned with MDR requirements to support regulatory submissions. - Gap Analysis: Evaluation of existing clinical data to identify gaps and strategies to address deficiencies, ensuring compliance with regulatory standards. This service ensures a systematic and compliant approach to clinical evaluation, supporting regulatory approval and lifecycle management of medical devices.

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

The placing of a medical device or an IVDon the market is preceded by an evaluation of the residual risks related to quality, safety and performance. However, this evaluation shall continue throughout the entire lifecycle of the device, including the post-market period. Post-market surveillance allows manufacturers to collect and analyze experiences of the actual use of medical devices. Based on the outcome of this analysis, further actions such as incident reporting to competent authorities, field safety corrective actions or safety warnings to users may be required. Post-market surveillance activities are planned in the Post-market Surveillance Plan and the data is compiled in the Post-marketing Surveillance Report - PMSR (for class I medical devices) or the Periodic Safety Update Report (for class IIa, IIb and III medical devices or class C or D IVDs). Our unit assists in the elaboration of the PMS Plan with the definition of actions and also the elaboration of PMSR or PSUR

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

IPN provides expert guidance in identifying the applicable pre-clinical tests required for medical devices, ensuring alignment with regulatory standards and facilitating a seamless pathway to market. The focus is on determining the specific tests based on the unique characteristics of the device, such as whether it is sterile, active, implantable, or software-based. Examples of pre-clinical tests include electrical safety and electromagnetic compatibility (EMC) evaluations, biocompatibility assessments (e.g., cytotoxicity, sensitization, and irritation testing), cybersecurity analysis, sterilization and cleaning validation, microbiological tests (e.g., bioburden and sterility), and stability or shelf-life studies. Additionally, IPN’s team assist in identifying accredited laboratories with proven expertise to conduct these tests, guaranteeing reliable and regulatory-compliant results.

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

The IPN team conducts thorough audits of Quality Management Systems (QMS) to ensure compliance with key regulatory requirements, including ISO 13485, FDA’s 21 CFR Part 820, and the European MDR and IVDR regulations. Independent auditors perform on-site or remote assessments to evaluate the effectiveness and conformity of the QMS, supporting both initial certification audits and ongoing surveillance or recertification audits.

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

According to Article 15 of the MDR, the manufacturer of medical devices is required to have, within its organization (or an external person for small companies), a person who is responsible for regulatory compliance and with the explicit responsibility to ensure that all 'Manufacturer's Obligations' are met (Article 10). Our team includes competent and experienced people to play the role of Person Responsible for Regulatory Compliance, ensuring: - The verification of the conformity of medical devices according to the QMS (Article 10(9), MDR); - Maintenance and updating of technical documentation (Article 10(4) and (6), MDR); - Compliance with market surveillance obligations (Article 10(10), MDR); - Fulfilling incident reporting obligations (Article 10(13), MDR).

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

IPN performs gap analysis, in order to assist the success of MD or IVD development projects, with the ultimate goal of making the devices available in the intended markets. This analysis identifies data gaps in projects, procedures, and product regulatory roadmaps, considering the regulatory requirements. The regulatory/market assessment gap analysis consists, among others, of the following steps: map out current policies and procedures; outline the regulatory and normative framework and determine which requirements the organization and/or project needs to meet; identify and analyze the gaps; establish concrete recommendations on how to resolve the gaps.

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

Risk evaluation gap analyses are designed to assess the potential risks and vulnerabilities associated with medical devices or IVDs. The IPN team assists companies by conducting comprehensive gap analyses of current risk identification and evaluation processes for their devices, identifying any shortcomings in the existing risk management framework. Leveraging the principles outlined in ISO 14971, the team evaluates the adequacy of risk management practices and ensures compliance with international standards. Based on this initial evaluation, the team can also support the development of an action plan to mitigate or eliminate identified risks effectively.

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

IPN includes qualified trainers who provide specialized training in the area of medical device regulation, with our greatest experience being in Regulation (EU) 2017/745, Regulation (EU) 2017/746, Risk Management (according to ISO 14971), Quality Management Systems (according to ISO 13485) and Performance and Clinical Evaluation. All trainings are accredited and can be in a face to face or online mode, divided into asynchronous sessions and synchronous sessions. In addition to specialized training and mentoring services, we also offer free webinars on the topics mentioned above.

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

The MDR and IVDR states in Article 10 (9), the requirements for the Manufacturer’s QMS. Despite not being specified, ISO 13485 is the most suitable quality management systems standard for medical devices companies. In the US, manufacturers must comply with the FDA’s Quality System Regulation (21 CFR Part 820), which outlines similar requirements for design, production, and process controls. The IPN helps medical device and IVD companies implement their QMS in compliance with the applicable regulatory framework. So, in order to meet the requirements and also operators’ specific needs, IPN team work closely with each section or department representatives.

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

The European database on medical devices (EUDAMED) improves transparency and coordination of information regarding medical devices available in the European market. The database consists of 6 modules, and IPN can assist organizations in using the modules already available, that is, in the registration of manufacturers, importers, and authorized representatives in the "Actor Registration Module" with the issue of the “Single Registration Number” (SRN), and in the device registration in the “UDI/Device Registration Module”

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

IPN team is able to bridge the gap between companies and the Notified Bodies. More specifically, the team supports the management of communication with the Notified Bodies during the certification submission process. This support includes guidance and support for the Notified Body selection according to the applicable product codes, assistance in requesting quotes, filling in the form, Gap analysis of the TD prior to submission and support in responses to Notified Bodies’ requests for additional information about submissions.

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

With special focus on active devices, IPN supports manufacturers, distributors, and importers of MDs and IVDs, in the CE marking process taking into account the applicable requirements of Regulation (EU) 2017/745 (Medical Device Regulation - MDR) or Regulation (EU) 2017/746 (In Vitro diagnostic Medical Device Regulation – IVDR), as applicable. In this context, IPN supports the implementation and review of the Quality Management System (QMS), together with the elaboration or revision of the Technical Documentation (TD) of the device (under Annex II and Annex III of MDR or IVDR). IPN also support the company, depending on the device class, with the submission of the certification request to a notified body.

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

IPN provides services related to the Unique Device Identification (UDI) system, which ensures proper traceability of the devices throughout the distribution chain and by the user. IPN assists in the registration of organizations within an accredited UDI issuing agency, in the creation and correct use of UDI codes (UDI-DI, UDI-PI and basic UDI), ensuring that UDI data is formatted correctly for submission to EUDAMED and/or Global Unique Device Identification Database (GUDID – FDA). IPN also provides support in the maintenance of data related to the UDI.

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

Vigilance means to be watchful of the possible danger or difficulties. The medical device Vigilance System is designed to collect information on post-market incidents or adverse events related to medical devices and, where appropriate, distribute or disseminate such information to prevent adverse events from recurring. This indicates that medical device manufacturers must have a dedicated system in place for the management of vigilance activities. It is the manufacturers or, if applicable, the European Authorized Representatives’ obligation to notify the Competent Authority in case of any incident with their devices. In the regulatory unit, we help manufacturers to implement medical device Vigilance Systems in compliance with all legal and regulatory requirements and also support incident reporting as well as incident investigation and further actions implementation.

CEED - Charité Healthcare Services GmbH

Our company-specific modular MDR-workshops offer hands-on training on various relevant topics of the Medical Device Regulation (MDR) and the general medical device field. These intensive workshops are divided into compact and practice-oriented modules that cover the key requirements of each respective topic. An example is the Module 1 workshop “Regulatory Requirements for Your Medical Device,” which provides a compact and practice-oriented overview of the key regulatory requirements in the medical device field. The workshop content is tailored to the company’s specific needs beforehand, and additional topics can be booked in modular fashion. Thus, specific topics such as Clinical Evaluations, Technical Documentation, and Quality Management can be booked individually and customized to the company's needs. The content is structured in such a way that participants are optimally prepared for the MDR requirements and can directly apply their knowledge. A regular workshop usually lasts two days and includes gap analyses in the form of checklists as well as the creation of an action plan. Practical exercises additionally introduce the creation of documentation and processes tailored to the individual company. Participants also receive current informational materials and clinical insights from practice. Our workshops provide companies with the opportunity to not only further educate individual employees but also empower their team to implement the MDR and other regulations within the company. Our goal is to strengthen and support the team in jointly managing the various regulatory requirements and to guide the transition from overview and understanding to practical implementation. Keywords: MDR Workshop, MDR, Medical Device Regulation, Modular Workshops, Hands-On Training, Medical Devices, Regulatory Requirements, Practical, Gap Analyses, Action Plan, Clinical Evaluation, Quality Management, Usability, Post-Market Surveillance (PMS), Post-Market Clinical Follow-Up (PMCF), Charité - Universitätsmedizin Berlin

CEED - Charité Healthcare Services GmbH

Our clinic-oriented regulatory strategy consulting offers comprehensive, individualized advice and support on specific issues in the medical device field. We assist you with product identification, clarify demarcation questions, and support product classifications as well as the selection and implementation of the conformity assessment procedure. Additionally, we maintain close contact and communication with the Notified Body to effectively meet your requirements. Our service also includes consulting on Quality Management Systems according to ISO 13485 and re-certification. Our experts support you in technical documentation, conduct gap and requirements analyses, and prepare you for inspections. We also offer internal audits to ensure that your systems and processes comply with current regulatory requirements and are continuously improved. Our consulting topics particularly include clinical evaluation, including advice on clinical strategy and clinical benefits, as well as equivalence assessment. We provide comprehensive advice on the selection of clinical data, determine the type and extent of required data, and recommend suitable data sources and methods of data collection, including Real-World Data (RWD). Furthermore, we support the assessment of evidence levels and classes, as well as ensuring data quality and quantity. In the area of Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF), we offer consulting on the development of PMS and PMCF strategies and support in individual PMS and PMCF activities such as studies and surveys. Additionally, we provide advice on the establishment and implementation of usability engineering and requirement processes to optimize the usability of your medical devices. Keywords: Regulatory Strategy, Consulting, Medical Devices, Intended use, Product Classification, Conformity Assessment Procedure, ISO 13485, Technical Documentation, Gap Analysis, Inspections, Internal Audits, Clinical Evaluation, Clinical Data, Real-World Data (RWD), Post-Market Surveillance (PMS), Post-Market Clinical Follow-Up (PMCF), Usability Engineering, Charité - Universitätsmedizin Berlin

CEED - Charité Healthcare Services GmbH

Our requirements analyses during design and development phases focus on the development of product ideas and include detailed investigations to identify technical, functional, and usability requirements. The analyses aim to define the exact specifications of the product, identify potential design improvements, and ensure that all development goals are met. They help in developing high-quality and marketable solutions that comply with industry standards and requirements. Requirements analyses may involve various activities, such as user interviews, workshops, and workplace and workflow analyses. Keywords: Requirements Engineering, Functional Requirements, Usability Requirements, Specifications, Usability Engineering, User Interviews, Expert Panels, Workplace & Workflow Analyses

Zilinska Univerzita V Ziline (UNIZA)

Consulting and development of serious games using Unity for healthcare, training, and educational applications. These interactive tools are designed to engage users while collecting valuable insights, supporting behavior change, or improving clinical and learning outcomes across multiple platforms including VR and AR. Technical details:Developed in Unity; supports WebGL, Android, Windows, VR/AR platforms. Use cases/examples: An SME with an AI system wants to develop an interactive and immersive training application. This application can be deployed as a virtual reality, server-client or standalone PC application.

Univerzitna Nemocnica Martin (University Hospital Martin)

The initial consulting session with duration of 2 hours for a small-to-medium enterprise (SME) focuses on understanding the client's needs, identifying key challenges, and setting a foundation for a successful cooperation. Here’s a structured breakdown of the session: - Introductions: brief background of the consultant and firm. - Objective Setting: explaining the purpose of the meeting and set clear expectations for the session. - Understanding client’s background: gathering information about the SME’s history, mission, vision, and values to understand its foundational context. - Discovery and needs assessment: reviewing the SME’s core business, products/services, and key markets, current challenges and SME's top pain points (e.g. financial performance and cash flow issues, operational inefficiencies, marketing and sales challenges, talent management and retention, regulatory or compliance needs) - Setting up next steps: plan for utilization of TEF services a.k.a. “plan for success” - Open Q & A: answering any client questions or share additional thoughts, gathering feedback Key words: business consulting, business development, needs assessment, “plan for success”

Istituto Giannina Gaslini (IGG)

Our service can provide consulting on designing, modelling, validation and testing of Trustworthy AI models in a realistic pediatric environment, it can provide information on the most relevant applications, Data types, needs, pitfalls, and peculiarities of a typical pediatric environment. It can provide support for typical challenges and solutions on data governance and infrastructures with acknowledged scientists in AI for pediatric needs. Service can connect company with experts in various pediatric medical disciplines; Hospital organisation; AI applications in pediatrics; Data exchange standards and infrastructures; Optimal algorithm development and testing for pediatrics; Methods for AI testing and validation; Data science; Data types in paediatrics. Prices are subject to change and are only indicative. The final price will be determined in the contract between the service provider and the applicant.

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

Annex XV of the MDR outlines the requirements for the documentation regarding the application for Clinical Investigations to be conducted within the European Union. Similarly, Annexes XIII and XIV of the IVDR outlines the requirements for the documentation regarding applications for clinical performance studies and other performance studies . 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 and competent authorities). In this context, IPN services include: -> Clinical Investigation Plans (CIPs) / Clinical Performance Study Plan (CPSP) -> Investigator’s Brochure (IB) -> Case Report Form (CRF) -> Informed Consent Form (ICF) -> Clinical Investigation Report (CIR) / Clinical Performance Study Report (CPSR) and Supporting Documentation -> Additional specific forms for local ethics committees and Competent Authorities in different countries. • Study Monitoring & Data Management, supporting the Site Initiation activities, recruitment process, monitoring, data collection/analysis and CIR/CPSR according to ISO 14155:2020/ PSR according to ISO 20916:2019 - Good Clinical Practices/ Good Study Practices. If needed, Study Coordination support may also be made available.

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Help to select and to use advanced deep learning algorithms to create custom and trustworthy AI models for medical image analysis (e.g. classification, segmentation, feature extraction, anomaly localization). Depending on the modality to be processed, we propose advanced deep learning architectures (CNN, LSTM, ViT, etc.) by selecting the best approach for the task to be performed (classification, localisation, segmentation, etc.). Keywords: Medical Image Analysis; Deep Learning Algorithms; Binary Classification; Anomaly Localization; AI Model Development; Real-World Images; AI Testing and Validation; Collaboration with Medical Staff; AI Expertise; Custom Pretrained Pipelines; Clinical Imaging; Image Segmentation; Image Feature Extraction; Trustworthy AI

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Challenge : Difficulties in identifying the needs of users, clients, and other stakeholders, particularly regarding the development of AI-based products, to ensure a focus on the right challenges. This service provides support for the activities needed to collect and analyze requirements for the development of an AI-based product (software and hardware). In addition, the service offers support in setting up a technology roadmap with a prioritization of functionalities to be developed. Our strength: Guiding you in gathering requirements, analyzing needs, and technological guidance to steer future development by applying co-creation and co-innovation techniques with the assistance of a network of specialized stakeholders. Keywords: Business Analysis

RISE Research Institutes Of Sweden

Method description: Add-on support to the service "AI improvement and development" available at RISE. The service includes support for training, deployment and installation. The service is customized according to the SME's needs. Method reference: To be refined depending on the type of task, and in dialog with the customer. The Center for Applied AI at RISE carries out cutting-edge research in AI, connects expertise and applications within RISE, and explores a wide range of innovative applications with industry and the public sector. Applied AI Centre at RISE helps companies and government agencies to see more potential in the technology, use it more wisely and develop it faster. Keywords: Trustworthy AI, Federated learning, Data Science, AI, Deep Learning, Natural Language Processing, Computer Vision, Machine Learning.

Health Cluster Portugal - Associacao Do Polo De Competitividade Da Saude (HCP)

This service is designed to deliver valuable insights into emerging trends in healthcare innovation, tailored to support SMEs in their specific business areas. Keywords: Trends; Market; Technology

Politecnico Di Milano (POLIMI)

Testing of technical specifications and analysis of the outcome in a relevant environment (testing phase before real environment testing). Example: when applicable, tests with healthy users are performed to verify technical functions and usability, before moving to tests with the target population (patients). Keywords: Validation, Usability

RISE Research Institutes Of Sweden

Methods description: The service of testing and validation of AI solutions with Deep Learning paradigms. The service can include suggestions of applications and highlight strengths, weaknesses, threats and/or opportunities. The service is customized according to the SME's needs. Pre-requisites for the service are the analysis of data availability, data-readiness level and customer needs. Method reference: To be refined depending on the type of task, and in dialog with the customer. The Center for Applied AI at RISE carries out cutting-edge research in AI, connects expertise and applications within RISE, and explores a wide range of innovative applications with industry and the public sector. Applied AI Centre at RISE helps companies and government agencies to see more potential in the technology, use it more wisely and develop it faster. Keywords: Trustworthy AI, Federated Learning, Data Science, AI, Deep Learning, Natural language processing, Computer Vision, Machine learning.

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Support iterative process of usability of the medical device prototype for CE mark. Includes the definition/revision of inputs for the usability specification according to the available documentation: - the intended use of the medical device - the risk analysis linked to usability - use scenarios Depending the SME needs, this service may be: - an expert evaluation by an ergonomist or; - support on protocol writing for formative evaluation. The proposed method is based on a user-centered procedure, as described in ISO 9241-210 on the ergonomics of human-system interaction, and complies with ISO 62366-1/ ISO 62366-2 on the usability of medical devices. Keywords: Usability test, Formative evaluation, Summative evaluation

CEED - Charité Healthcare Services GmbH

Our workplace and workflow analyses provide insights into the workflows and environments within the clinic, including the analysis of processes, the physical work environment, and the interaction with other devices and technologies. They can also be used to examine workflows and challenges with existing products. Workplace analyses are crucial for understanding the requirements for designing and integrating new products, ensuring that they can be seamlessly incorporated into existing workflows, taking into account user needs as well as safety and efficiency standards. Keywords:Workplace Analyses, Workflow Analyses, Process Analyses, User and Clinical Requirements, Usability Engineering