Overview

There is a mountain of information on FDA regulation and compliance for medical device manufacturers. The task is daunting and very few busy manufacturers are regulatory mountain climbers. Reading the regulations provides only a small part of the picture. Understanding what the regulations mean and how compliance can be achieved in your environment is the key. Graphic icons organize the text and provide a visual aid to definitions, regulations, procedures, documents, records, and points to remember. Applicable chapters also end with an FDA investigator icon, which summarizes what the FDA investigator will expect to see during an investigation. The book opens flat for your convenience.

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