5 Differences Between ISO 13485 and FDAs Medical Device QSR Iso 13485 Vs 21 Cfr 820
In this 2-part series of Medtech Snapshot we're joined by Square-1 Engineering Director of Delivery & Operations Trisha Aure as ISO 13485 vs. CFR Part 820 Links 21 CFR 820.140: ISO 13485:2016 § 4.2.3, On February 23, 2022, the FDA published a proposed rule for medical device quality system regulation amendments. The FDA SUBSCRIBE to @FDALearningCache to see more videos. Details and supporting materials: ...