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Blog Post Expert Panels MDRPNG

References

 “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: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=OJ:C:2020:259:FULL&from=EN

Medical Device Regulation (EU) 2017/745, Official Journal of the European Union: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745




Blog post QSR QMSPNG

References

Office of information and regulatory affairs, “Harmonizing and modernizing regulation of medical device quality systems”: https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202004&RIN=0910-AH99

FDA, “Transition to ISO 13485:2016”: https://www.fda.gov/media/123488/download

FDA, Quality System Regulation, Code of Federal Regulations Title 21, Part 820: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820

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