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