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Europe needs to act over international device QS (quality system) standard

This article was originally published in Clinica

Executive Summary

The revised international medical device quality system standard, ISO 13485, could be published by May. The final draft international standard (FDIS) is due to be published imminently, and this will be followed by a two-month vote which is expected to proceed smoothly. This was the latest news given on the standard given by Maria Donawa, president of Donawa and Associates, at the mdt 2003 conference in Birmingham (UK) on February 13.

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