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Free On-Demand Webinar

Understanding the Changes to ISO 13485:2016

Presented by: Mark Swanson, a Member of the Standard's Working Group

Today's medical device regulatory environment is changing faster than ever. Keeping up can be daunting. The new quality management standard ISO 13485:2016 was published in Q1 of 2016. has partnered with special guest and consultant, Mark Swanson, to keep you ahead of these changes.

Mark spent the last 4 years on the working group that revised the new ISO 13485.

Mark has all the exclusive insider knowledge on the changes you want. And he's going to be sharing it with you for free.

In this webinar you'll learn specifically:
  • How to prepare for the coming regulatory changes with ISO 13485:2016

  • How to apply risk based thinking to your quality processes to ensure compliance

  • What you need to know about the design control updates

  • How to incorporate ISO 9001:2015 and 13485:2016 to your supplier controls

  • A general overview of the standard and its most significant changes (before anyone else)

 What Some People Have Said:

"Thank you for the notices on the "Understanding the Changes to ISO 13485:2016" webinar training; I attended the session and found it very informative. Mark Swanson and Jon Speer both did great jobs. I got quite a few facts concerning the changes to ISO 13485 out of the training and expect to pick up even more in the detailed deck offer that I received after the session. Excellent program!!" -Quality Manager (CQE, CQA)


"This was a great presentation and I've really learnt a lot. Thanks for providing me the opportunity to participate." -Board Member of Medical Device Company


"Appreciate your presentation, it was an eye opener for the new standard. Thanks!" - QA Manager at Large Medical Device Manufacture


Your Presenters:


Mark Swanson 


President / Principal Consultant, H & M Consulting Group



Jon Speer

Founder & VP QA/RA,

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