Compliance Blog

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Blog Post Expert Panels MDRPNG


 “Commission guidance for the medical devices expert panels on the consistent interpretation of the decision criteria in the clinical evaluation consultation procedure”, Official Journal of the European Union:

Medical Device Regulation (EU) 2017/745, Official Journal of the European Union:

Blog post QSR QMSPNG


Office of information and regulatory affairs, “Harmonizing and modernizing regulation of medical device quality systems”:

FDA, “Transition to ISO 13485:2016”:

FDA, Quality System Regulation, Code of Federal Regulations Title 21, Part 820:

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