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ISO seeks views on changes required for pivotal medtech quality system standard

This article was originally published in RAJ Devices

Executive Summary

The ISO Technical Committee (TC) that is overseeing changes to ISO 13485:2003, the medtech quality system standard based on the ISO 9001 generic quality system standard, has launched an online survey to assess the need for updating this standard and the related ISO/TR 14969:2004 guidance document1.

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