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New ISO 13485 Out In June 2016, Amidst Flood Of Updated EU Standards

This article was originally published in Clinica

Executive Summary

In Europe, the definitive text of the latest version of ISO/DIS 13485:2015, the most widely used medical device quality management system standard, should be available by June 6 next year. At least that is the target set by the European Committee for Standardization (CEN), according to its timetable.






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