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![]() For this reason, national and international regulatory agencies require medical device manufacturers and providers to demonstrate that they have a quality management system (QMS) that has been audited and certified by an external body.Ĭertification bodies generally base their audits on the EN ISO 13485 standard "Medical devices: Quality management systems - Requirements for regulatory purposes." This addresses the requirements that medical device manufacturers and suppliers must meet in developing, implementing, and maintaining quality management systems. The quality and effectiveness of medical devices affect the safety of patients, users and others more than many other products. ![]() ![]() Why use checklist to audit for ISO 13485 certification? ![]() ![]() > Each stage ends with a progressively harder boss fight. FGTeeV - Mystery Figures Blind Bag - Season 2 Assortment. ROBLOX RONALD the COP! Today we have to get out of clown prison! S2:E17 | | 12m. 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