How to Get Ready for 21 CFR Part 820/ISO 13485 Harmonisation

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In 1997, the U.S. Food and Drug Administration (FDA) launched its Quality System Regulation (QSR), 21 CFR Part 820, governing the quality management systems of medical device manufacturers.

Around that same time, the International Organization for Standardization (ISO) rolled out its global quality management system standard, ISO 13485. Both were important steps toward ensuring the development of high-quality, safe, and effective medical devices.

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