In this course you will learn what changes are occurring in regulatory standards, including ISO 10993, Medical Device Regulations, and FDA guidance. Then based on these changes you will learn how to keep your biocompatibility program current.
Changes are in the pipeline for ISO documents, the new MDRs, and FDA guidance. You will learn what these changes entail and how to best address them.
Thor S. Rollins, B.S., RM (NRCM)
Director, Toxicology and E&L Consulting
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 many published 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.