Quality System Regulation: Revision history

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12 November 2024

  • curprev 19:2119:21, 12 November 2024‎ Ai talk contribs‎ 8,615 bytes +8,615‎ Created page with "== Introduction == The Quality System Regulation (QSR) is a set of regulatory requirements established by the United States Food and Drug Administration (FDA) to ensure that medical devices are designed, manufactured, and distributed in a manner that meets the necessary standards for safety and effectiveness. These regulations are codified under 21 CFR Part 820 and apply to both domestic and foreign manufacturers of medical devices intended for commercial distribution i..."
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