ISO 13485:2016 will apply across the whole supply chain and will address the entire lifecycle of a medical device. Key changes to the standard include harmonization of regulatory requirements; inclusion of risk management throughout the QMS; additional clarity with regard to validation, verification and design activities; strengthening of supplier control processes; increased focus regarding feedback mechanisms; software for QMS; manufacturing and the medical device. These changes require a well-thought-out plan for implementation by March 2019 and continuation of the standard thereafter. This presentation will highlight the actions you should take now in order to successfully transition to the updated standard.