In the midst of an evolving biocompatibility testing and regulatory environment, MedTech professionals face the challenge of staying informed of biocompatibility testing and regulatory trends. Intended to provide MedTech professionals the knowledge and expertise to navigate the challenges inherent in contemporary biocompatibility testing, the upcoming MD&M Minneapolis tradeshow is slated to offer four lectures by Nelson Laboratories biocompatibility expert Thor Rollins.
“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.”
Biocompatibility test methods and regulatory behavior have changed dramatically over the last four years. While the future of biocompatibility testing hints at faster, more accurate, cost effective test methods, the contemporary regulatory environment has become increasingly complex. Changes to the ISO standard and diverse regulatory interpretation and application means that 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. It is these unforeseen complexities that make understanding current biocompatibility testing trends so important for MedTech professionals.
Courtesy of Nelson Laboratories, Thor will be presenting four consecutive biocompatibility testing and compliance focused lectures beginning Thursday October 30th at 10:30 am central time.
MD&M Minneapolis tradeshow participants will be given complimentary access to Mr. Rollins’ three Tech Theater presentations which will include discussion of the Big Three, the power of chemical characterization, and how the new FDA ISO 10993 guidance could affect you.
Thor’s final presentation will focus on the latest FDA trends in biocompatibility testing for cardiovascular devices. This is a conference presentation scheduled to begin Thursday October 30th at 2:45pm. Registration is required.
The Big Three: Cytotoxicity, Sensitization, & Irritation
10:30 am – 11:15 am, October 30th
The Power of Chemical Characterization to Assess Changes in Your Medical Device
11:30 am – 12:15 pm, October 30th
How the New FDA Guidance on ISO 10993 Could Affect You
12:30 pm – 1:15 pm, October 30th
Hemocompatibility and the FDA: The Latest Trends From The FDA
2:45 pm – 4:00 pm, October 30th
Requires MD&M Minneapolis registration. CLICK HERE to register.