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Webinar 5: Getting ready for QMSR

In the first of a series of webinars on this topic, we review additional risk-based requirements for a QMS under the upcoming Quality Management System Regulation (QMSR).

In February 2022, the FDA proposed an amendment to the current Quality System Regulation (QSR) for medical devices to align it more closely with the international consensus standard ISO 13485:20161. The amended regulation, when approved, will be referred to as the Quality Management System Regulation (QMSR) to better reflect the emphasis on the managemen…

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QMSR Compliance
Resources to get you ready for QMSR compliance