Deb Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions
How much effort will it take to get your organization ready for ISO 13485:2016? The new quality system requirement takes effect in March 2019. Medical device manufacturers that aren’t prepared for this change will need to do some heavy lifting to stay compliant with the updated standards.
Do you know if you need to do light or heavy lifting to get ready for the new version of ISO 13485? Here is some insight on where to start when reviewing changes between the old and new standard.