21 CFR Part 820: Complete Guide to Medical Device QMS Compliance
10 min read
21 CFR Part 820 serves as the cornerstone of regulatory compliance for medical device manufacturers operating in or exporting to the United States. This regulation, also known as the Quality System Regulation (QSR), establishes current good manufacturing practices (CGMP) that manufacturers must implement to ensure their products consistently meet both FDA requirements and customer expectations. […]
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