Tag Archives: Inspection

Devine Guidance

FDA Issues a Warning Letter with no Plant Inspection! What?

By Dr. Christopher Joseph Devine
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If your establishment is planning to introduce a medical device into commerce, it is incumbent upon the organization to correctly classify the medical device and obtain the appropriate clearance/approval before offering the finished device for sale or advertising on your establishment’s website. Failure to do so will end badly.

If your establishment is planning to introduce a medical device into commerce, it is incumbent upon the organization to correctly classify the medical device and obtain the appropriate clearance/approval before offering the finished device for sale or advertising on your establishment’s website. Failure to do so will end badly.

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

Inspection, Measuring, and Test Equipment

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

Inspection, measuring, and test equipment form a significant part of the quality-system foundation for successful medical device manufacturers. Device manufacturers need effective tools to gage adherence to approved product specifications; and the vehicle employed for doing so is the performance of acceptance activities utilizing inspection, measuring, and test equipment.

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