WATCH NOW - What You Need To Know about ISO 13485:2016

ISO 13485:2016 is the first major revision to the global quality system standard since 2003. In this one hour recorded webinar we cover the major changes that have been made and tell you what needs to be done before you seek recertification by your Notified Body.


  • Timeline for certification transition for current certificate holders and new ISO 13485 certifications
  • Comparison with other management standards and global regulatory expectations
  • Brief overview of the significant changes made between the 2003 and 2016 versions
  • Review of emphasized areas for the quality system that are expected moving forward
  • Planning methods for certification transition and new certification

Who Should Watch:

This recorded webinar is appropriate for anyone responsible for QA compliance. It is expected that attendees will have knowledge of ISO 13485 already as we will not cover the basic concepts of the existing standard and will focus on the changes instead.

Recorded December 2016

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Download our white paper on ISO 13485:2016 and How It Impacts Medical Device Companies Free white paper: How ISO 13485:2016 Impacts Medical Device Companies
The new ISO 13485 revision is finally here. You probably have plenty of questions about how the new standard will affect your company: Do I have to completely overhaul my QMS? When do I have to comply? Download now.