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Medical Device Quality Standard EN ISO 13485 To Be Available Earlier Than Expected In EU

This article was originally published in SRA

Executive Summary

The date by which the definitive text of the medical device quality system standard, EN ISO 13485, should become available in Europe has been brought forward by three months. CEN, the European Committee for Standardization, notes that the text should be available on March 29 2016 in its latest snapshot of standards that are due to become available soon or that are on its work program1.

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