Tag Archives: DHR

Devine Guidance

Accurate DHRs are Never Optional

By Dr. Christopher Joseph Devine
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FDA feels so strongly about the importance and composition of the DHR, that the Quality System Regulation (21 CFR, Part 820) contains a section dedicated to this.

FDA feels so strongly about the importance and composition of the DHR, that the Quality System Regulation (21 CFR, Part 820) contains a section dedicated to this.

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

Device History Record

By Dr. Christopher Joseph Devine
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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 820.184 (Device History Record). The Device History Record (DHR) is a collection of activities such as production routers, as-built configurations, test and inspection results, copies of labeling, etc., retained for a specific device or batch of devices. Device manufacturers can take it to the proverbial bank: DHRs will be scrutinized during a routine inspection.

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