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Light At The End Of The Tunnel: Redo Of ISO 13485 Chugs Forward With Final Draft, But Could It Be Derailed By European 'No' Votes?

This article was originally published in The Gray Sheet

Executive Summary

The International Organization for Standardization is prepped to begin voting on the updated ISO 13485 early next year, but the co-convener of the work group revising the widely used international quality systems standard worries about some countries voting 'no' because the reworked ISO 13485 will not use ISO's so-called "high-level" document approach. In the end, "we've done as much as we can; if particular countries want to vote 'no' on the docket because of the high-level structure and vote 'no' again on the FDIS [final draft standard], then so be it," ISO TC210/Working Group 1 co-chair Ed Kimmelman says. "We're hoping we still have enough votes to get the FDIS approved and the document published as an approved standard."

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