The ISO 13485:2016 standard was released on February 26, 2016. It has been 12 years since the medical device standard has been updated. Companies now have 3 years to transition from the 2003 version. If you need more information check out our ISO 13485:2016 Medical Device Standard or News tabs, and subscribe to our free periodic ISO News Updates. If your company has an ISO 13485 system in place, or are planning to have such a system, subscribe to the DAC Audit Services ISO 13485 News Updates to learn more.