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How to Effectively Evaluate Change and Incorporate Findings into Biocompatibility Testing and Justifications

Change Management, especially related to a medical device’s design, is one of the most commonly-cited issues in FDA 483s and Warning Letters. Unfortunately, change is constant in the medical device industry, so it’s imperative to learn how to effectively evaluate change and incorporate findings into biocompatibility testing and documentation. In this webinar, industry expert Thor Rollins from Nelson Labs will teach you how to:

  • Accurately identify change
  • Evaluate change’s impact on biocompatibility and testing
  • Effectively and proactively predict and document rationale of changes
  • Remain compliant when changes inevitably occur


Thor Rollins | Nelson Labs

Toxicology and E&L Expert
Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles on biocompatibility topics.
He is a participating member on all Association for Advancement of Medical Instrumentation (AAMI) TC 194 and 10993 ISO committees and plays an active role along with the FDA and regulatory committees developing standards, discussing biocompatibility methods, and voting on changes to those standards. As one of a select group of experts in the industry, Thor’s participation on the committees offers him insight on industry changes and helps prepare clients for changes in testing.

On-Demand Video

Webinar Resources

The Testing and Risk Management Impacts of Changing a Medical Device