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CATEGORY: STANDARDS
Usability Engineering
The application of human factors engineering to medical devices per IEC 62366-1. Ensures that devices can be used safely and effectively by their intended users. Required by FDA and EU MDR for all device classes.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
Usability engineering (IEC 62366 / FDA human factors) reduces use-related hazards. Required evidence depth scales with risk of use error—especially for home-use and high-risk devices.
PROCESS / STEPS
- Identify critical tasks and use-related hazards from risk management.
- Conduct formative studies; iterate UI/IFU design.
- Perform summative validation with representative users and use environments.
- Document residual use risks and training/labeling mitigations.
EXAMPLES
- Home-use injectors and infusion pumps almost always need robust human factors validation packages.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Usability Engineering across 27 authorities in real time.
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