Learn from RQM+ subject matter experts who are solving clinical evidence challenges for our clients every day. Please join us!

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RQM+ Live! is a biweekly and interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device and diagnostics industries. The panelists also answer audience questions. Every episode is added to our podcast, too.

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RQM+_Live_36_RecordedWe're back for part two! With so many questions we couldn't address during our April 22, 2021 show on this topic (available on demand), we needed to come back a second time. This is clearly a topic many of you are interested in and we want to help. In fact, we can't wait and hope you'll join us!

"Insufficient clinical evidence" is the most popular and arguably the most difficult notified body deficiency to address. This finding comes in many shapes and sizes, as do the possible solutions. In this Live! episode, our panel of experts will discuss the following and more:

  • What types of clinical evidence gaps are notified bodies citing?

  • What are some solutions to enable keeping your devices on the market?

  • What's the best approach to documenting clinical evidence weaknesses in your technical documentation, to improve your odds of notified body acceptance?

  • How do you leverage your PMCF plan as a mitigation for clinical data weakness?

  • How do you make all of the documentation sing together - CER, PMCF plan, SSCP, Risk file, labeling - providing a cohesive clinical evidence story to the notified body that they can feel good about approving?

Our panel includes Amie Smirthwaite, former Head of BSI Global Clinical, and Jai Kutty, just months out of BSI, along with RQM+ subject matter experts who are solving clinical evidence challenges for our clients every day!

  • Amie Smirthwaite, Ph.D. - Global VP, Clinical Regulatory Services

  • Jaishankar (Jai) Kutty, Ph.D. - VP, Clinical Regulatory Services

  • Jon Gimbel, Ph.D. - Executive Director, Regulatory and Quality Consulting Services

  • Sally Sennitt, MBBS, FRCA - Medical Director

 

 

“I am amazed at how much work and the number of decisions that have been made to date on this project! I really appreciate the effort and patience of the entire RQM+ team! Lots of work to go in 2021, but I am grateful that the RQM+ team is helping us manage through this process.”

Director, Regulatory Affairs
IVDR Implementation Project for a Global Medical Device and Diagnostics Manufacturer