Important Changes To ISO 13485 2016 For Medical Device Manufacturers And Designers

By Christine Berard, KMC Systems

The ISO 13485:2016 quality management and regulatory requirement standard that was published in early 2016 established a new international framework to mitigate risk and produce effective medical devices. Those who wait too long to transition their QMS to the updated version may face problems such as certification bottlenecks and market-entry roadblocks. In order to help medical designers and manufacturers, KMC Systems outlines the most important changes to consider in this article. Download the full article for information on the new documentation, sources of quality data, competence, overall QMS effectiveness and more.