Compliance
IEC 62366
Medical devices — Application of usability engineering · 62366 · usability engineering
TL;DR
The usability-engineering standard for medical devices — analyse use, identify use-related hazards, design to mitigate, validate with representative users. Required under MDR, IVDR and FDA QMSR.
IEC 62366-1:2015 (and the 62366-2 guidance) requires manufacturers to apply a usability-engineering process: use specification, user interface specification, use-related hazard identification, summative evaluation. The output is the Usability Engineering File, normally bundled into the DHF.
Closely linked to ISO 14971 (use-related risks are risks) and FDA Human Factors guidance (Feb 2016).
Regulatory anchors
- IEC 62366-1:2015
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