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cGMP and ISO 13485 Integrated Quality Management System

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The Food and Drug Administration (FDA) has established and maintains Part 820- Quality System Regulation (QSR), also known as 21 CFR 820 or 'Current good manufacturing practice' (cGMP). This regulation applies to medical device manufacturers or importers of devices intended for 'human use.' Compliance with this regulation is expected from any organization that manufactures or imports such devices into the USA. 

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