Changes to standards in recent years, what’s on the horizon for 2022, answers to common questions, and more!

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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_45_Recorded

Generating evidence of biocompatibility continues to be a significant challenge to regulatory submission success and product-to-market timelines.  And global requirements and interpretations continue to evolve, further increasing the challenge.  In this show, we will discuss the changes to standards in recent years, what’s on the horizon for 2022, and answers to common questions we receive like the following:

  • Is the biocompatibility approach different for US and EU? 
  • When should you consider a chemical characterization approach?
  • How do you use exemptions for intact skin devices made of common materials (US)?
  • What’s the best process for managing changes to material or manufacturing processes?
  • What can you change and still claim equivalence?
  • What new developments have there been in 2021?

Please join our esteemed panel of subject matter experts including former FDA CDRH and BSI leaders:

  • Jaishankar (Jai) Kutty, Ph.D. VP, Intelligence & Innovation
  • Nancy Morrison, RAC - Executive Director, Regulatory & Quality Consulting Services
  • Jonathan Gimbel, PhD - Executive Director, Technical Leadership, Clinical & Post-Market Practice
  • Kevin Go - Project Engineer (former FDA CDRH Lead Reviewer)

"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