ISO 13485:2016 Overview

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This workshop will provide you with a concise but detailed review of the new ISO 13485 Medical Devices Quality Management System standard. We will compare the 2016 version to the 2003 version, and explain the new requirements of the 2016 standard. We will also talk about transitioning from to the 2016 standard, including timing requirements. Activities include developing a “List of Interested Parties” for your QMS. There will also be time for questions and answers.

Note: If you have a copy of the ISO 13485 standard, bring it with you to the workshop. 


  • Describe the history and purpose of ISO 13485.
  • Identify major changes to ISO 13485:2016.
  • Explain the timing requirements for transition to ISO 13485:2016.
  • Describe a process for transitioning to ISO 13485:2016.

Appropriate for

Management representatives, quality professionals, personnel functioning as internal auditors, and others interested in learning about the new ISO 13485:2016 requirements.


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