ISO 13485:2016 is here! 

ISO 13485 is evolving to keep up with changes in the medical device industry. First released in 2003, a revised ISO 13485 was published on February 25, 2016. You have until March 2019 to update your current ISO 13485 certificate to the new version.

In our Market Update, Impacts and Opportunities Presented by the Major Changes in ISO 13485:2016, we explore:

• The major changes to the revised standard.
• The impacts and opportunities presented by these changes.
• Recommended next steps to ensure a successful transition.

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