Tag Archives: medical devices

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

Quality System 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 820.186 (Quality System Record). The Quality System Record, not to be confused with the Quality System Regulation, can be a document/procedure that points to where all documentation, procedures, and other records, required by the regulation are located, within the context of a device manufacturer’s quality system. The key for compiling a QSR and ongoing compliance with the QSR (y…

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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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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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