Live! #64 – The Evolving Biocompatibility Landscape: Staying Ahead of Regulatory Requirements

Device Advice by RQM+

This is audio from RQM+ Live! #64, recorded 16 February 2023. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.

Over the past several years the expectations for testing of medical devices per the ISO 10993 standards has significantly changed and continues to change at a rapid pace. Furthermore, different regulatory bodies have different expectations when evaluating this data. Failure to understand these expectations and an inappropriate choice of testing labs can result in product delays and repeat testing.

The expert panel will:

• Describe how chemical characterization, toxicological risk assessment and biological testing work together to evaluate a device
• Explain how to ensure method sensitivity, maximize quantitative accuracy and identification confidence
• Highlight which validation experiments are expected for chemical characterization
• Discuss the major points of departure between European notified bodies and US FDA
• Explain which certifications are necessary for laboratories
• Show how controls used, and when are they necessary in biological testing
• Evaluate how revisions to ISO 10993-17 may impact toxicological risk assessment

Panelists:

• Joel M. Cohen, Sc.D., DABT – Principal, Gradient
• Jaishankar (Jai) Kutty, Ph.D. – Vice President, Intelligence & Innovation, RQM+
• Kevin Rowland – Director of R&D, RQM+
• Taryn Meade – Director of Biological Evaluation Consulting, RQM+
• Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation, RQM+ (moderator)