SALT LAKE CITY, UT – October 24, 2014 – Representing veteran microbiology lab Nelson Laboratories, LLC, recognized biocompatibility expert Thor Rollins who will present at MedTech industry trade show, MD&M Minneapolis, on the evolving nature of medical device biocompatibility testing standards in relation to regulatory behavior.
Over the last four years biocompatibility test methods and regulatory behavior have changed dramatically. While the future of biocompatibility testing hints at faster, more accurate and cost effective test methods, navigating the contemporary regulatory environment has become increasingly complex. Understanding current biocompatibility testing standards in the context of regulatory behavior is necessary for MedTech professionals.
“Right now we have a very exciting, dynamic, and sometimes challenging biocompatibility testing landscape. I have been on the ISO Committee for almost 12 years and we have never seen as much development in the 10993 standards as we have in the last several years.” Rollins said. “We are in what I would consider the new age of biocompatibility testing.”
Coupling of changes to the ISO standard with diverse regulatory interpretation/application means merely establishing a testing scheme will be wrought with challenges. According to Rollins, it is not uncommon for regulators to request additional testing beyond the scope of the current ISO 10993 standard.
Mr. Rollins’ conference presentation, Biocompatibility Testing For Cardiovascular Devices: The Latest Trends From The FDA, will be Thursday October 30, 2014 2:45 pm – 4:00 pm. Course highlights include an overview of hemocompatibility studies and what endpoints they access, how the FDA is applying ISO 10993-4, evaluating a change to an existing device, and an update from the latest ISO 10993 meetings in Japan.
MD&M conference participants will also have access to Rollins’ half-day biocompatibility Tech Theater session from 10:30 am – 1:15 pm Thursday October 30, 2014. Tech Theater topics include The Big Three, The Power of Chemical Characterization, and How the New FDA ISO 10993 Guidance Could Affect You.
About Thor Rollins: Thor Rollins is a certified microbiologist who specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. Mr. Rollins is a participating member of all AAMI 10993 ISO committees and plays an active role in developing standards, discussing biocompatibility methods, and voting on changes to those standards. Thor currently works as the biocompatibility consulting manager for Nelson Laboratories, a leading provider of microbiology testing and consulting services for MedTech companies. Learn more at www.nelsonlabs.com.
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