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How The 'Unusual' Makeover Of ISO 13485 Will Impact Device Manufacturers

This article was originally published in SRA

Executive Summary

Experts from the International Organization for Standardization (ISO) will be meeting for three days in the UK from August 25 to hammer out a final draft of the long-awaited revision of the medical device quality management system standard, ISO 13485:2003, one of the most widely used standards in device manufacturing1.

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