This is the audio-only version of RQM+ Live! #33, originally recorded May 6, 2021.
"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 include Amie Smirthwaite, former Head of BSI Global Clinical, and Jai Kutty, just weeks 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
Celeste Maksim, Ph.D. RAC - Senior Manager, PMS and PMCF Services
Sally Sennitt, MBBS, FRCA - Medical Director
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