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What is Overview of 21 CFR Part 820 Regulations about?

This document outlines the quality system regulation for medical devices. It establishes basic requirements for quality management including management responsibility, quality audits, design controls, document controls, purchasing controls, production and process controls, acceptance activities, nonconforming products, corrective and preventive action, labeling and packaging, handling, storage, distribution and installation.

Author

gtconsultancy

Language

EN