Tag Archives: Supplier Statistical Data

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

Identification and Traceability

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

The identification and traceability (sections 820.60 and 820.65) for products and finished medical devices, throughout the entire manufacturing process, including raw materials employed during the manufacturing process, and the subsequent sale and distribution of medical devices, are critical elements of the Quality System Regulation (QSR).

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

Gage R & R and Reduced RI Programs

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

Since the concept of writing a weekly blog and actually having a following is somewhat foreign to me, I was not sure what to expect or the reception I would receive writing a weekly column. So far, the support and responses have been overwhelmingly positive; and for that, I would personally like to thank the readers. Additionally, I will continue to write about and provide relevant information associated with supplier quality (four installments remaining) and will eventually begin addressing quality and…

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