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Historically, biological safety evaluations for medical devices were comprised of an investigation into biocompatibility tests required to meet regulatory obligations. Put simply, medical product manufacturers would contract with a testing laboratory, evaluate the lab’s proposal and accept the recommended product evaluation plan.
In today’s world, however, the simplicity of the above process is increasingly questioned given the recent requirements of ISO 10993-1: Biological evaluation of medical devices; Part 1 – Evaluation and testing within a risk management process. This is in part due to the requirement set forth within ISO 10993-1 that indicates medical device manufacturers go beyond the minimalistic process of identifying a set list of biocompatibility tests when evaluating a device’s biological safety.
This webinar, presented by Don Pohl (Manager of U.S. Biological Safety & Validation Services, NAMSA), will take a look at the basic requirements of ISO 10993-1 and how device organizations can effectively identify processes to meet regulatory standard for multiple regulatory bodies.
Questions to be addressed include:
Time will also be allotted for Q&A.