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A Long, Twisted Path To Revision: How The 'Unusual' Makeover Of ISO 13485 Will Impact Device Manufacturers – And Why There Isn't Much They Can Do About It Now

This article was originally published in The Gray Sheet

Executive Summary

Staying the course has been an ongoing challenge for the International Organization for Standardization as it works overtime to revise ISO 13485, one of the most widely used quality system standards in medical device manufacturing. There have been obstacles to the latest revision of ISO 13485: some ISO member-countries voted against drafts of the standard for no apparent reason; an inordinate number of industry comments had to be reviewed one-by-one; and the document's redo bumped up against the revision of an even bigger, broader international standard, ISO 9001 – just to name a few headaches – but ISO's Technical Committee 210 hopes to finish a final draft of the standard at an upcoming meeting in the UK.

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