On February 23, 2022, the FDA released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR) with the international consensus standard for medical-device quality management systems, ISO 13485:2016.

Cue the applause—the medical device industry has been buzzing about harmonization between the FDA’s 21 CFR Part 820 and ISO 13485 since 2018, and now it’s finally happening.

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