However, in addition, the authors of the EU MDR have highlighted some specific EU requirements items which must be present for the QMS to be EU MDR compliant. ![]() Nevertheless, one can see that the QMS requirements in the regulation largely correspond to the sections of the Standard. At the time of writing an update of Annex Z of the Standard, the explanation of the relationship between the Standard and the Regulation, is still anticipated. On this page “the Standard” means EN ISO 13485:2016. Those familiar with the EU’s medical device QMS standard, EN ISO 13485:2016, should immediately recognise the similarities with Article 10, 9. ![]() ![]() The requirements for the Manufacturer’s Quality Management System (QMS) are contained in Article 10, 9.
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