Nelson Labs hosted a tech theater and half-day seminar at the 2019 MD&M West tradeshow in New York City, NY. The video of the tech theater is available as well as the PDF of the presentation from the seminar. Contact [email protected] for more information.
Tech Theater Lecture
Topic: The New “Big Three” Biocompatibility in vitro Alternatives Are At Our Door
Presenter: Thor Rollins, Director of Toxicology and E&L Consulting
Watch the on-demand video HERE.
Half Day Seminar Track
Biological Safety Evaluation: Using a Risk-Based Approach for Biocompatibility
Speaker: Thor Rollins, Director, Toxicology & E&L Consulting, Nelson Labs
This seminar summarizes how biocompatibility of medical devices is evaluated from a risk-based approach, based on the most recent feedback from FDA. The presentation focuses on the aspects most relevant to anyone who may influence the design, engineering, and quality assurance of devices. An introduction is given to the ISO 10993 standards and FDA guidance documents for medical devices as they apply to medical device manufactures. Focus is given to:
- Biocompatibility risk analysis
- How to use the risk analysis results for biocompatibility
- FDA trends in approaches to biocompatibility testing
- How chemistry is being used as an approach to biocompatibility
- How to evaluate the impact of changes to biocompatibility
Understanding biocompatibility and associated testing is essential to all involved in the development and manufacture of medical devices. Issues that can be challenging for a final, finished device from a biocompatibility perspective may be easily prevented. Part of this seminar is in lecture format, while part is comprised of interactive, hands-on case studies.
Download the presentation slides HERE.
Chemical Characterization and Toxicological Risk Assessment for Medical Device Biocompatibility
Speaker: Matt Jorgensen, PhD, Chemistry & Materials Scientist, Nelson Labs
- How extractable/leachable chemistry testing will save them time and money
- How this testing strategy increases patient safety
- How approaches to evaluation of biocompatibility are evolving to focus even more chemistry
Download the presentation slides HERE.
