Tag Archives: Supplier controls

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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Devine Guidance

Handling Bad Product

By Dr. Christopher Joseph Devine
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Unfortunately, Mr. Murphy is alive and well in the medical device industry, and it is inevitable that device manufacturers will have to handle non-conforming product.

Unfortunately, Mr. Murphy is alive and well in the medical device industry, and it is inevitable that device manufacturers will have to handle non-conforming product.

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