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  • White Paper

ISO 13485:2016: The Route to CE Marking for Medical Devices

ISO 13485 is an essential standard in the medical device industry and is an internationally recognized standard for QMSs.

Young woman working in laboratory, handling test tubes

ISO 13485 Quality Management System 

The ISO 13485:2016 is a useful standard because it specifies requirements for a quality management system (QMS) when an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Download this white paper to learn more about ISO 13485:2016 and CE audit:

  • Get an overview of the ISO 13485:2016 standard for medical devices
  • How ISO 13485:2016 helps manufacturers address regulations and fulfill responsibilities in order to facilitate compliance with CE requirements
  • How MDR, IVDR, IVDD and MDD requirements have an impact on your CE certification 
  • How UL can help you achieve CE certification

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