7/11/2023 0 Comments Quality manual iso 13485![]() 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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