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What is the difference between iso 13485 and 21 cfr 820 full#
Handling, storage, distribution, installationįor a full list of requirements, click here.Some of the regulation and requirements for medical device manufacturers include:
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The revised version became effective on June 1st, 1997. This replaced the old Good Manufacturing Practice (GMP) for medical devices, and was revised so that regulation would be more consistent internationally. These requirements are called current good manufacturing practices (CGMP). Quality System Regulation (QSR), also known as FDA 21 CFR Part 820, is a system that ensures that medical devices meet quality and safety requirements.