New ISO 13485 On Medical Device Quality Due In June 2016; Amidst Raft of Updated EU standards
This article was originally published in SRA
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, which also lists a raft of standards that are predicted to become available between now and 2018.
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