Changes to ISO 13485 2016 for Medical Device Manufacturers, Designers

Published early in 2016, ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes establishes a new international framework to mitigate risk and produce effective medical devices. Christine Berard
As the new standard now clarifies that a company’s QMS “shall meet customer and applicable regulatory requirements for safety and performance,” the time is now to revise the QMS in a way that demonstrates compliance to all standards, specific to your device and market-entry plans. For example, it’s necessary to show all regulatory documentation, for each device that you design, manufacture and bring to market. KMC Systems
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