HUMAN FACTORS VALIDATION TESTING

In medical device human factors research (according to MDR, IEC 62366, FDA Guidance on applying UE to medical device development, AAMI HE75 and other standards) HF validation testing is an essential part for the final market approval (CE and FDA 510(K)) of your medical device. In the test sessions, we examine if your product can be used safely and effectively by its intended users, in its intended use environments, for its intended purposes.

Including detailed root cause analysis…
We conduct thorough root cause analysis of all observed use errors, close calls, and operational difficulties to determine if a residual use-related risk is acceptable or if additional risk mitigation is necessary. At the end, we deliver an HF validation report formatted according to FDA guidance for easy integration in the overall usability engineering file.