7/1/2023 0 Comments Iso 13485 version 2003![]() "When we did the last review, we had discussions with the regulatory authorities and we - both industry and the authorities - felt that it was time to revise the standard … Since 2003, a number of jurisdictions have either revised or introduced regulations for medical devices, so we want to make sure the quality management system requirements align fully with those regulatory requirements." The consensus was that the old standard no longer reflected current quality management needs.Īccording to Eamonn Hoxey, former chair of ISO’s technical committee for quality management: When the 2003 standard was reviewed, ISO staff discussed potential revisions with a variety of regulatory bodies. ![]()
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