GHTF regulatory audit reports: final document posted
This article was originally published in Clinica
Study group 4 of the Global Harmonization Task Force, which focuses on quality system audit practices, has posted a new final document on its website on regulatory audits reports in the context of guidelines for regulatory auditing of quality managements system of medical device manufacturers. The document is entitled N33R16:2007 and was posted on November 19. There a total of seven documents posted as final documents by Study Group 4 on its website, amounting to 96 pages worth. Final documents are those which have been agreed by each of the five founding members of the GHTF - EU, US, Canada, Australia and Japan - and which are then available for adoption or implementation by member national regulatory authorities.
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