We had more questions than we could answer on this topic in our 16 December, 2021 RQM+ Live! show, so we're back for more. Please join us!

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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_52

During our previous show on this topic we were flooded with questions from viewers (which we love!) and couldn't answer them all, so we're back for a sequel. This show will answer all the questions we ran out of time to answer previously and address additional questions if you have them!

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.

Rollover questions we'll kick the discussion off with:

  • Have you had any unique or unexpected feedback from notified bodies or FDA? Have you seen misinterpretations by the regulators?
  • What is the difference between Physical and/or chemical information vs chemical characterization?
  • For reusable devices, has there been any requests for "biocompatibility over the lifetime" per ISO 10993-1:2018, and if so, how is this typically handled?
  • Is it necessary to have a toxicologist expert interpreting chemical characterization data?
  • What do you do if you have a large number of unknowns in chemical characterization?
  • How do you use exemptions for intact skin devices made of common materials (U.S.)?
Please join our esteemed panel of subject matter experts including former FDA CDRH and BSI leaders:
  • Jaishankar (Jai) Kutty, Ph.D. - VP, Intelligence & Innovation
  • Kevin Go, RAC - Project Engineer (former FDA CDRH Lead Reviewer)
  • Lucie Dalet, Ph.D. - Senior Regulatory 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