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ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO)standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. ISO 13485:2016 is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices throughout the world. Certification to ISO 13485 requires its quality system to pass a 3rd party MDSAP audit. |
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