Episode description
This is the audio from RQM+ Live! #45, originally recorded 16 December, 2021.
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?
Here's the 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)
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About RQM+
RQM+ is the leading international provider of regulatory, quality, and clinical consulting services for medical device and diagnostics manufacturers. The company delivers transformative solutions by providing unrivaled collective expertise fueled by passion for client success. The experts at RQM+ are collaborative, laser-focused on client needs and committed to delivering high-value solutions that exceed expectations. For more information, please visit RQMplus.com.