For medical devices to be truly safe and effective, they must work as intended in the hands of real users, in real environments. For many years, regulatory bodies have acknowledged this and require human factors analyses and documentation. That’s where our extensive experience in Human Factors Engineering for medical products becomes essential. Use errors and poor usability aren’t just inconvenient. They can result in medical errors, harm patients and delay regulatory clearance/approval.
The Eurofins Medical Device Services network of laboratories specializes in the design and delivery of practical Human Factors strategies, analyses, and end-user testing of medical devices. We have the experience necessary to support regulatory requirements, identify use-based risks, and evaluate how users interact with your medical device or combination product in preparation for human factors engineering documentation.
With more than 20 years of experience and thousands of product types evaluated, our expertise spans all levels of complexity, product types, and systems including:
- Class I, II, and III Medical Devices
- Collection and Diagnostic Kits
- Combination Products
- Emergency Use Products
- Kits and Container Closure Systems
- Laboratory Instrumentation
- Software as Medical Devices
We partner to define your human factors strategy and plan, conduct comparative analyses of your device/product relative to others, and conduct formative and validation testing of your device/products in simulated settings. Whether your device is used in a home, hospital, pharmacy or operating room, your devices/products will be tested where they are used, by the people who’ll be using them.
Ensure your device performs safely in real-world use.
