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.
To hear more about the FDA’s current harmonizatoin efforts and how companies are navigating the evolving landscape, watch the full replay of this Veeva MedTech Summit session on Veeva Connect.
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