It embodies an agreed upon, repeatable way of managing production, validation, quality, and risk management.Īt the heart of ISO 13485:2016 is a comprehensive risk management process meant to be implemented in all medical device-related quality management processes within an organization, including processes that occur after the medical devices are placed on the market. ![]() ISO 13485:2016 is the management system that governs medical devices, the management system upon which compliance with regulatory and customer compliance can be built. Eamonn Hoxey, Chair of ISO technical committee ISO/TC 210, Quality management and corresponding general aspects for medical devices, the patient comes first.
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