This article covers the differences between QMSR, ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP) so leaders can prepare for the upcoming changes.
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Citation:
Brehm P. Getting ready for the FDA’s upcoming QMSR. Regulatory Focus. Published online 29 August 2022. https://www.raps.org/news-and-articles/news-articles/2022/8/getting-ready-for-the-fdas-upcoming-qmsr