Overview

This service provides a structured technical assessment of biomedical hardware, custom sensors, and instrumentation prototypes for health applications. Conducted by SMAILE at Karolinska Institutet, the evaluation focuses on device design, integration, signal fidelity, power consumption, and suitability for clinical or field use. From wearable biosensors to lab instruments, our team helps ensure your innovations meet scientific, technical, and regulatory expectations.

We provide expertise and support in: • Biomedical device prototyping and test bench validation • Signal stability, hardware reliability, and functional safety • Pre-compliance testing and integration readiness

How can the service help you?

Innovators often struggle to identify design flaws or performance issues in early prototypes. This service accelerates development by identifying bottlenecks, verifying functionality, and preparing devices for clinical or usability trials.

How will the service be delivered?

Hybrid model: virtual consultations, remote analysis of schematics and performance data, and physical testing at SMAILE’s facilities. Duration: 2–6 weeks, depending on complexity.

Additional Information

Provider Description

SMAILE at Karolinska Institutet supports digital health and medtech innovation through technical validation services, regulatory support, and usability testing for medical technologies.

Technical Description

Assessments cover sensor calibration, signal noise analysis, data synchronization, power management, interface protocols, and durability under simulated use conditions. Testing follows ISO and IEC standards for electronic health devices, and supports both standalone and integrated system evaluations.

Service Customization

Clients may focus the service on device subcomponents (e.g., battery life, enclosure design), specific functions (e.g., HR monitoring), or integration with software/data systems.

Keywords: biomedical hardware testing device prototyping sensor validation hardware reliability medical device testing instrumentation testing signal fidelity power consumption testing functional safety pre-compliance testing device integration prototype validation hardware design evaluation calibration testing test bench validation medical instrumentation clinical device assessment hardware durability

Offerings: Hardware (Design, Development, Manufacturing, etc.) Testing Pre-Clinical (Neurology, Cardiology, wearables, motion, psychophysical, GLP, animal safety, toxicity, etc.)

Provider & Contact

Provider Organisation Karolinska Institutet (KI)

Provider Country Sweden

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

Service Inputs Device prototype or sample, technical specifications, schematics, firmware documentation, sample data logs, intended use description

Service Outputs Comprehensive technical validation report including performance benchmarks, identified design issues, recommendations for improvement, test results with supporting data, and readiness assessment for next development phase

Dependencies & Restrictions Requires physical delivery of hardware prototype (for lab testing); technical documentation must be provided in English; CE/FDA regulatory compliance certification not included in scope; testing limited to biomedical and health applications; NDA agreements apply; intellectual property protection maintained throughout assessment

Tech Validation Hub: Assessment of Custom Biomedical Devices and Hardware

Service Description