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

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RQM+_Live_59

MDCG 2022-2 was intended to provide guidance on how to demonstrate clinical evidence, however we continue to receive so many questions and requests for support around this topic.  The concept that clinical evidence is not clinical performance can still be hard for manufacturers to get their heads around, especially considering the cost and effort it will take to demonstrate clinical evidence.  

In this show, our experts will discuss:

  • Differences between clinical evidence and clinical performance, and where we see manufactures struggle
  • Notified body expectations and what they will not allow to pass
  • Steps to generating data that will be accepted by the notified bodies, and our lessons learned so far; and
  • Challenges and guidance on generating clinical evidence for specific IVDs, like general use devices and instruments

Please join our esteemed panel of industry experts and former notified body IVDR leaders and bring your toughest questions to be answered.

  • Carlos Galamba, MSc  Vice President of IVD Intelligence & Innovation
  • Heike Möhlig-Zuttermeister​, Ph.D.  Vice President of IVD Intelligence & Innovation
  • Bethany Chung, Ph.D., RAC Principal Regulatory Scientist
  • Ron Sills Senior Principal Specialist

"With partners like you I feel even more confident. I’m very appreciative of how you are presenting both short and long term solutions and speaking your ‘regulatory philosophy’ out loud."

Director, Clinical Compliance, Multinational Medical Device Manufacturer