Module6 April 20264 min read
Module spotlight: Usability & Human Factors
Most use errors are design problems, not user problems. Usability and human-factors work makes a device safe in real hands, to IEC 62366-1.
By MoniDoseQMS Team
When a device is used incorrectly, the instinct is to blame the user. The standard takes the opposite view: most use errors are designed in, and can be designed out. Usability and human-factors work makes a device safe and intuitive in the hands of the people who actually use it.
What you can do
- Document user experience and usability work
- Run usability studies, including for dispensing devices
- Connect use-error findings to risk management
- Build the human-factors evidence a submission expects
Why it matters
IEC 62366-1 makes usability engineering a formal expectation, and use-error risk is part of ISO 14971 risk management. Treating usability as a design discipline — not a user problem — is what makes a device genuinely safe in practice.