Watch RQM+ Live! on demand
On Thursday, 16 February 2023, RQM+ subject matter experts hosted episode #64 of our Live! show. Fill out the form to get access to the on-demand recording now.
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
- 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+
- Nancy Morrison, RAC – Vice President, Intelligence & Innovation, RQM+ (moderator)
Please sign up to access the recording by filling out the form.