White Paper: cGMP And ISO 13485 Integrated Quality Management System

By MasterControl

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.

The ISO 13485 Standard is widely used in the medical device manufacturing industry as a means of establishing compliance with Canadian Medical Device Regulation and European Medical Device Directive. Since the majority of medical device manufacturers comply with both 21 CFR 820 QSR and ISO 13485 standards, it is practical to consider establishing an integrated 21 CFR 820 and ISO 13485 Quality Management System (QMS).

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