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Organizations already certified to ISO 13485:2003 have until March 1, 2019, three years from the date of publication, to transfer to the new version.

ISO 13485 Readiness Checklist

To make things easier for you, we have developed a Readiness Checklist to help you understand all the requirements of ISO 13485:2016 and what you must do to ensure a smooth transition.

Our checklist outlines the changes to the standard in simple terms and highlights the areas where you may already comply, so you know exactly what your next steps should be. Working through the Readiness Checklist will provide you with valuable insights and guidance.

Get the ISO 13485:2016 Readiness Checklist >>

For more information on transitioning to ISO 13485:2016, please contact us so we can help you make the transition under the best possible conditions and satisfy your timelines.

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