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What is ISO 13485:2016?
ISO 13485:2016 is an international standard that specifies requirements for a Quality Management System (QMS) for organizations involved in the design, production, and distribution of medical devices.Who should consider ISO 13485:2016 certification?
Organizations of any size involved in the medical device industry—such as manufacturers, suppliers, and service providers—should consider certification to ensure product quality and regulatory compliance.What are the key changes from ISO 13485:2003 to ISO 13485:2016?
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