A review of the changes in ISO 13485

On February 25, 2016, the International Organization for Standardization (ISO) published its revisions to ISO 13485 replacing the previous version from 2003. This is the global standard for medical device quality management systems (QMS). Over the next three years, ISO 13485:2003 and ISO 13485:2016 will coexist, allowing manufacturers, accreditation/certification bodies and regulators time to transition to the new standard.

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