
ISO 13485:2016: The Logical Route to CE Marking for Medical Devices and In Vitro Diagnostics Medical Devices
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ISO 13485 is an essential standard in the medical device industry and is an internationally recognized standard for QMSs.
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:
ISO 13485:2016: The Logical Route to CE Marking for Medical Devices and In Vitro Diagnostics Medical Devices