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