ISO 13485 is the revised standard which outlines the Quality Management System requirements for medical devices.
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ISO 13485 is used in conjuction with ISO 9001 as a basis for assessing the Quality Management System implemented and maintained by manufactures of medical devices.
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ISO 13485 provides the specific requirements for compliance, leading to declaration of conformity of production quality assurance to be certified by a third party body, in connection with CE marking of the medical devices.
