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21 CFR 820: Navigating Medical Device Quality Systems
Dive into the critical components of 21 CFR Part 820, the Quality System Regulation that governs the medical device industry. Our guide offers detailed insights into compliance with handling, storage, distribution, installation, and labeling, as well as the nuances of design controls, document management, and purchasing controls. It provides a breakdown of the subparts for corrective and preventive action, non-conforming products, quality audit procedures, and the importance of traceability. Perfect for quality assurance professionals, regulatory affairs specialists, and medical device manufacturers, this resource ensures you stay compliant with FDA regulations and maintain the highest standards of quality and safety.
Edited at 2022-05-08 13:06:59
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