This book provides insights into the causes of failures to comply with the quality regulations of the Food and Drug Administration. It describes the reasons for the compliance failures and the actions that can be taken to assure that the FDA quality auditor does not discover significant observations of nonconformance.
From the Publisher
Mort Levin is an acknowledged authority in the actions necessary for compliance with the quality regulations of the Food and Drug Administration. Most of his industry career of over thirty years as a designer, manager of design, and manager of quality and regulatory affairs has been devoted to assuring the only quality medical devices were designed and manufactured.
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