ISO 13485: Medical Devices Standard

This standard represents the requirements for a comprehensive management system within the design and manufacture of medical devices. This standard is somewhat unique in that some of its requirements separate it from the main ISO 9001 quality management standard, so many organizations that are ISO 13485 compliant, are not able to also be ISO 9001 compliant. Some of these unique considerations include the need to ensure all medical devices are sterile, the ability to track and inspect devices that are implanted in patients, and the management of risk during product development.


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