ISO 13485 is the revised standard which outlines the Quality Management System requirements for medical devices.


ISO 13485 is used in conjuction with ISO 9001: 2000 as a basis for assessing the Quality Management System implemented and maintained by manufactures of medical devices.


ISO 13485 provides the specific requirements for compliance, leading to declaration of conformity of production quality assurance to be certified by a notified body, in connection with CE marking of the medical devices.

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