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NAMSA Webinar: ISO 10993 Update: Understanding the Use and Value of Biocompatibility Standards for Medical Devices
November 29, 2017 @ 12:00 pm - 1:00 pm
Join BioOhio member NAMSA for this webinar on November 29 from 12 pm – 1 pm.
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 successfully fulfill this regulatory standard for multiple regulatory bodies.
Questions to be addressed include:
- What tools are available to device manufacturers to help identify an appropriate testing strategy?
- How does chemical characterization testing fit into an overall biological evaluation plan?
- When are specific tests unnecessary, and what determines this?
- Does a “check box” approach still guarantee regulatory approval?
Time will also be allotted for Q&A.