Historically, biological safety evaluations for medical devices were comprised of an investigation into biocompatibility tests required to meet regulatory obligations. However, since 2009, the emphasis on a risk management process and characterization of materials continues to shift the biological safety paradigm. Put simply, the days of medical product manufacturers simply contracting with a testing laboratory, reviewing and accepting a recommended product evaluation plan is no longer a globally accepted practice.
In today’s world, there is continued interest in how an evaluation is conducted long before any biological tests are performed. And, with the release of ISO 10993-1:2018 in August 2018, there is a continued focus in biological safety planning and implementation processes, as well as the characterization of materials. Once again, medical device manufacturers are being asked to go beyond the simple process of identifying a set list of biocompatibility tests when evaluating a device’s biological safety.
This webinar, presented by Don Pohl (Principal Product Development Strategist, NAMSA), will take a look at the major changes introduced within ISO 10993-1:2018, and also discuss how manufacturers can efficaciously prepare for implementation of these new requirements.
Questions to be addressed include:
Time will also be allotted for Q&A.
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About the Presenter
Don Pohl, Principal Product Development Strategist
Don R. Pohl joined NAMSA in 1993. He holds a BS in biology from The Ohio State University. He has over 20 years of experience in the medical device industry, having worked in various roles all involving the non-clinical/pre-clinical evaluation of medical devices. During his career, he has held a variety of positions ranging from laboratory supervision / management, GLP Study Director, Technical Specialist covering in vitro/in vivo evaluation of medical devices, Manager of NAMSA Biological Safety and Validation Services, and his current role of Principal Product Development Strategist. His expertise is in the areas of sample preparation per ISO 10993-12 and the design of pre-clinical, in vitro/in vivo evaluations based on ISO-10993-1, FDA Guidance, and other relevant regional and international standards.