IEC 62366-1 & ISO 14971 Usability & Risk Management - Annex

✅ IEC 62366-1 & ISO 14971 combination table & flowchart (Possible scenario)

✅ Clear definitions of abnormal Use, Normal Use, Correct Use, Use error, & Reasonably Foreseeable Misuse

✅ Key terms to master

✅ Fundamentals of usability in risk management (User-device interaction model & Use Failures)

✅ How to perform a Root Cause Analysis of medical device use errors?

✅ Root cause analysis tools in medical use errors

17 pages, digital download