Tag Archives: General Requirements

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Records (General Requirements)

By Dr. Christopher Joseph Devine
Dr. Christopher Joseph Devine, President, Devine Guidance International

In this edition of Devine Guidance (DG), Dr. D will provide guidance for 21 CFR, Part 820, Subpart – M (Records), specifically 820.180 (General Requirements). General requirements are boring; however, just like basic blocking and tackling drills in football, device manufacturers must get the basics correct.

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