Tag Archives: training

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

Purchasing Controls

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

FDA is really taking medical device manufacturers to task in regards to purchasing controls and the overall management of their suppliers. According to Kimberly Trautman, FDA’s current Good Manufacturing Practices (cGMP) and Quality System Regulations (QSR) expert, suppliers providing non-conforming material are directly related to an increase in medical device recalls; which increases the need for effective quality processes to mitigate risk. As the medical device industry continues to grow in leaps and…

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

Document Controls

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

The control of documentation is one the fundamental cornerstones supporting the foundation needed for an effective quality system, whether compliance is to EN ISO 13485, EN ISO 9000, the Medical Device Directive, or in the case of this series of Devine Guidance articles, the Quality System Regulation (QSR).

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

Design Transfer, Design Changes and Design History File

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

In this fourth and final foray into Subpart C – Design Controls, Dr. D will review the last three subsections; (h) design transfer, (i) design changes, and (j) the design history file (DHF), located within section 820.30. These final three elements of design control are just as important as the previous subsections dissected as part of Devine Guidance.

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