IEC 62366 usability engineering, use-related risk analysis and critical task identification, and formative versus summative usability testing.
Use error, not device malfunction, is one of the largest contributors to medical device adverse events, which is exactly why IEC 62366-1 is a harmonized standard under both the EU MDR and FDA's recognized consensus standards list, and this module builds the usability engineering process the standard requires — distinguishing genuine use error from normal variation in use and from abnormal use, and identifying critical tasks through use-related risk analysis before a single prototype is tested.
It then covers formative usability testing, the iterative, low-stakes evaluation that shapes an interface design early, versus summative usability testing (human factors validation), the final, statistically powered study performed on production-equivalent devices with representative users performing representative critical tasks — closing the loop back to the design validation concept introduced in Module 2.