MD101 supports you in bringing your QMS into compliance with 21 CFR 820, also called Quality System Regulation (QSR).
Generally, MD101 customers start from an ISO 13485 certified QMS to implement specific QSR requirements.
Since the 2016 edition of ISO 13485, these requirements represent small adjustments. This is why it is also possible to set up an ISO 13485 + 21 CFR 820 QMS starting from a blank sheet. The effort required by the additional requirements of 21 CFR 820 can easily be integrated into an ISO 13485 certification project.
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