When it comes to testing your device’s validation, it is critical to have the appropriate simulated test environment, the expertise to meet regulatory expectations, and the means to identify and recruit the appropriate participants that reflect your intended users. And if human factors validation testing is left too late, or is poorly executed, it can derail approval altogether. Eurofins Medical Device Services network of laboratories mitigates that risk. With decades of experience, deep regulatory insight, and specialized facilities, we ensure your device is tested in the right way, by the right people, in the right setting.

Eurofins Medical Device Services conducts everything from authoring the human factors validation/summative protocol and study design through to submission-ready Human Factors Engineering Summary reports and support during regulatory reviews. Our teams draw on use-related risk analyses (URRAs) to build robust test scenarios for your device, users, and environments to ensure all required user tasks are tested in naturalistic and non-biased ways. We’ve planned and executed tests across a wide range of medical devices, combination products, and OTC products in various simulated use environments ranging from hospital rooms and homes to mass casualty scenes.

Whether your study needs 15 participants or 200+, our experienced team recruits highly relevant user groups of physicians, surgeons, patients, caregivers, and many more. Once testing is complete, our human factors experts generate clear, concise, and compliant human factors validation reports with thoughtful root cause analyses and evaluations of residual risk. A Human Factors Engineering Summary report will be generated for inclusion with your premarket submission. 

Build a confident human factors validation strategy.