Wednesday, December 24, 2008

FDA QSR Human Factors Reqs - Intro

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

Additional Resources & Previous Posts:
The FDA's Human Factors Program (promoting safety in medical device use)
6 Free FDA QSR Design Controls Tutorials
FDA CDRH Online Courses (Free)
Free 21 CFR Part 820 QSR Audit Checklist

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