CERs - Tips, Tricks, and Lessons Learned

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Clinical background on the new requirements.

This webinar was originally presented in May of 2018 and is now available on demand.

Here's some positive feedback from the live webinar:

  • "It was excellent. Lots of good information. Our process has been reviewed a few times by our NB with no issues, but there are things you guys presented that will make our process even more robust. So, thank you. Well done."
  • "Fantastic presentation. I've been struggling with SOTA for some time, and it really helps to learn how other writers are approaching the issue."
  • "Good Job guys!!! I really like the way the webinar is structured."
  • "Very good presentation. Thank you!"
  • "Very good - like/agree with the point that the audience for CERs is the notified body/auditor."
  • "Excellent lessons learned examples."

 You have heard about the increased requirements for clinical evaluation with MEDDEV 2.7/1 Rev 4 and the MDR. You may be working on new templates and updating your CERs.

And now come the questions...

  • What do these requirements really mean?
  • Why are we doing this?
  • How are we going to get this all done?

In this webinar, you’ll get the clinical background on new CER requirements from Dr. Dan Lace. Dr. Dan brings a physician’s perspective to unpack concepts like “state of the art” and “sufficient clinical evidence.” He’ll talk about how clinical evidence informs clinical practice, and how evidence-based medicine techniques are applied to CERs.

Then you’ll get insight on the mechanics of putting these concepts into practice from Ryan Kasun, CER Program Manager at R&Q. Ryan will talk about the lessons that R&Q has learned as we’ve walked alongside our clients through the MEDDEV 2.7/1 Rev 4 transition, and he’ll give tips and tricks for the next transition to MDR compliance.

What’s Covered:

  • What is evidence-based medicine, and how does it relate to CERs?
  • What does “state of the art” mean, and how do I write about it in my CERs?
  • What is “sufficient clinical evidence,” and how do I know if I have it?
  • What are notified bodies saying?

Key Takeaways:

  • Clinical background on regulatory requirements
  • Practical tips and guidance for implementation
  • Valuable insights from experienced leaders

 Access the on-demand webinar