Tag: producers
QM certification for producers of medical devices
Under QM certification If one refers to the certification of a quality management system (QM or QMS system) by a certification office. The certification confirms the certified company that its QM system is sufficient for a standard, generally a standard (for example ISO 9001, ISO 13485) or a law (for example MDR, IVDR). 1. Who…
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Applicability of the law for producers as an operator
This article examines the applicability of the law for the producers of medical devices and IVDs, which NO Bring products based on artificial intelligence to the market. Among other things, he answers the question if a manufacturer should take into consideration the artificial intelligence act if he uses chatgpt or develops an artificial intelligence system…
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