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3 Ways to Prepare for ISO 13484/Part 820 Harmonization
3 Ways to Prepare for ISO 13484/Part 820 Harmonization
In 2018, the U.S. Food and Drug Administration (FDA) began entertaining the idea of harmonizing its regulatory requirements for the medical device quality system regulation (QSR)—detailed in 21 CFR Part 820—with the requirements in ISO 13485. The resulting regulation would be called the Quality Management System Regulation (QMSR) and would require medical device manufacturers to develop a quality management system (QMS) that meets the standards of ISO 13485.
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