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Published 3 May 2019

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SafetyCulture Content Team

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What is ISO 13485:2016?

ISO 13485:2016 is an international standard developed by the International Organization for Standardization (ISO) for the Quality Management System (QMS) of organizations involved in the manufacturing, distribution, servicing, and disposal of medical devices. Organizations with ISO 13485:2016 certification are recognized to produce medical devices that are at par with industry standards.

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