FDA issues online video QSR training

FDA has posted 2 training videos. The FDA CDRH webpage for online training courses are at the link provided. The training entitled: Quality System Regulation 21 CFR 820 Basic Introduction, is a video by FDA Quality Systems Expert Kim Trautman. She steps through key portions of the regullation. At 66 minutes 26 seconds she discusses 820.70(i) and discusses spreadsheet validation as an example. She stresses limited black box testing for intended use according to a protocol rather then full design control and V&V activities.

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IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

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Software Risk Management

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Software Verification

IEC 62366 Usability Process and Documentation

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