Tag Archives: Device Master Record

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

Device Master Record

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

In this edition of Devine Guidance , Dr. D will provide guidance for 21 CFR, Part 820, Subpart – M (Records), specifically 820.181 (Device Master Record). Ensuring the DMR is the receptacle for the appropriate type of records and the ongoing sustaining of the DMR are the basic salient requirements associated with 820.181. Remember, the DMR will never remain in a steady state.

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