What’s the difference between FDA human factors requirements and IEC 62366?

Описание к видео What’s the difference between FDA human factors requirements and IEC 62366?

The FDA recognizes IEC 62366. Why isn’t that enough for a submission?

Is the difference between “human factors” (HF) vs “usability engineering?” (UE)

Why don’t submission deficiencies match the FDA’s current 2016 guidance?

Why does the FDA seem to be using the 2022 draft guidance already?

Why can’t we use data collected from outside the USA?

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