Medical Devices

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Medical Device Regulation 2017/745

Code of Federal regulation
21 CFR 820

The Medical Device Regulation (MDR) 2017/745 is the applicable European law for all economic partners involved in medical devices.

The 21 CFR 820 is the applicable law of the USA for all economic partners involved in medical devices.

Medical Device QMS ISO 13485

21 CFR 820

The ISO 13485 is the Quality Management System for Medical Devices applicable to the EU and other jurisdictions.

The 21 CFR 820 is Quality System Regulattion (QSR) for medical devices applicable to the USA. Sometimes, it is referred to as Medical Device GMP.