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6 1 promote the adoption of quality management principles by medical device servicers quality management principles and processes as part ofa quality system have been adopted and.

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This document provides guidance to the fda field staff on a new inspectional process that may be used to assess a medical device manufacturer s compliance with the quality system regulation and. The quality systems for fda regulated products food drugs biologics and devices are known as current good manufacturing practices cgmp s. The quality systems for fda regulated products food drugs biologics and devices are known as cgmp s. Overview of the quality system regulation for medical devices fda small business regulatory education for industry redi silver spring md september 30 2015 tonya a.

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