FDA QSR Human Factors Reqs - Intro

Updated April 17, 2019

The links in the original post broke.

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Human Factors and Medical Devices on FDA.gov

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OK, now I get it. I understand this topic quite a bit better after reading Human Factors MD's "FDA Human Factors Requirements." This is applicable for medical devices that need to follow the FDA's regulations on Do It By Design: An Introduction to Human Factors in Medical Devices and Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management. Even better, the folks at Human Factor's MD, cite section 820.30 of the QSR, in paragraphs c, f, and g, and walk us through the meaning and application of those paragraphs. Did you find it helpful too? These three paragraphs cover . . .

• design input
• design verification
• design validation

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