Director, Toxicology and E&L,
Nelson Labs, LLC
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.
AREAS OF EXPERTISE
Biocompatibility – ISO 10993 in vivo & in vitro studies Study design and test selection, justifications, product and regulatory considerations
Material Characterization – ISO 10993 analytical studies Study design and test selection, justifications, product and regulatory considerations
Class I, II and III devices including orthopedic, cardiovascular, pulmonary, disposables
US FDA 510(k), EU and international medical device submissions
Regulatory test design and justifications, test requirements for biocompatibility
Member of TC 194 AAMI / ISO 10993 working group 2003-Present