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It’s time for the FDA to fully embrace ISO 13485
Read this article to understand a little more about FDA Quality System Regulation (QSR) 21 CFR Part 820 and the need for the FDA to adopt ISO 13485 certification for medical device manufacturers.
Informazioni sul contenuto
FDA Quality System Regulation (QSR) 21 CFR Part 820 was written in 1997 to work in tandem with ISO 13485:1996. The purpose was to alleviate some of the burden on medical device manufacturers who had to meet two different standards: the FDA regulation and ISO 13485.
Yet in 2003, ISO 13485 was changed so significantly that the FDA QSR was no longer aligned with it. Now the FDA wants to update the QSR to bring it in line with ISO 13485:2016. But will this solve the problem? Can the FDA and the industry use the new QSR cooperatively?
In this article, Grant Ramaley explains the need for the FDA to adopt ISO 13485 certification to comply with regulations governing quality system management for medical device manufacturers.
Informazioni sull'autore
Grant Ramaley
Grant Ramaley is the director of regulatory affairs for Aseptico Inc., a manufacturer and marketer of dental support equipment in the United States and Canada since 1975. Ramaley also is co-chairman of the Regulatory Affairs and Standards Committee for the Dental Trade Alliance, Convener for the ISO 13485 Medical Device Working Group at the International Accreditation Forum, and Technical Committee Advisor to the Global Harmonization Working Party.
