Tag Archives: medical devices

Devine Guidance

FDA versus the Notified Body

By Dr. Christopher Joseph Devine

This week, the doctor provides you a brief parody on the little differences and nuances between FDA and your friendly notified bodies.

This week, the doctor provides you a brief parody on the little differences and nuances between FDA and your friendly notified bodies.

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Devine Guidance

Accurate DHRs are Never Optional

By Dr. Christopher Joseph Devine

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

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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Devine Guidance

SCAR – A Favorite Acronym

By Dr. Christopher Joseph Devine

Medical device manufacturers should have a tool for communicating supplier issues back to their suppliers; and it’s always better to have documentation.

Medical device manufacturers should have a tool for communicating supplier issues back to their suppliers; and it’s always better to have documentation.

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Devine Guidance

So You Received a 483 from FDA, Deal with it!

By Dr. Christopher Joseph Devine

It’s okay to disagree with a Form 483 observation; however, it is up to the offending organization to draft a salient response that delineates the points of disagreement.

It’s okay to disagree with a Form 483 observation; however, it is up to the offending organization to draft a salient response that delineates the points of disagreement.

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