1/15/2024 0 Comments En iso 134852016 standards![]() ![]() The processes required by the ISO 13485:2016 standard concern quality management for medical devices, much like the FDA 21 CFR Part 820, also known as the Quality System Regulation (QSR). Medical device manufacturers that comply with the ISO 13485:2016 requirements have processes in place to ensure device quality and safety to their customers. It can be used by an organization involved in one or more stages of the life cycle of a medical device.Īny company involved in the design, development, manufacturing, storage, delivery, installation, or technical support of medical devices must be able to prove that its products and related services consistently meet customer and regulatory requirements. The ISO 13485:2016 is an international regulatory standard that specifies medical device manufacturers’ Quality Management System (QMS) requirements. What Is the ISO 13485:2016 Quality Management System Standard?
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