Thor Rollins’ presentation will provide an overview of the FDA guidance on how to apply ISO 10993-1 and special requirements for colorants on October 11-12, 2017 during the 510(k) Workshop in Amsterdam.
The new FDA guidance on ISO 10993, a new draft of ISO 10993-1, changes to cytotoxicity, increase role of risk analysis, and the increase use of material characterization. If these changes in biocompatibility requirement have you in knots, or you are developing a device that needs a biological evaluation, then join us for two presentations by Thor Rollins at the 510k Workshop in Amsterdam on October 11-12, 2017.
On-Demand Webinars by Thor Rollins
Thor also recorded two on-demand webinars that are available to watch on the Nelson Labs website:
Changing a colorant in an approved medical device, what should I know?
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About the ISO 10993-1 Biocompatibility Speaker
Thor Rollins is Director of Toxicology and Extractables and Leachables (E&L) Consulting at Nelson Laboratories, LLC in Salt Lake City, Utah. He 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 Northern Cali Biomed ASQ group meeting in 2010 and 2012 as well as published articles on biocompatibility topics.
He is a participating member on all Association for Advancement of Medical Instrumentation (AAMI) 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.
Thor can be reached by email at firstname.lastname@example.org or by phone at: +1.801-290-7832.