Originally Aired - Wednesday, September 25 • 10:30 AM - 11:15 AM Eastern Time (US & Canada)
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Location: Med Tech Theater
Title: Biocompatibility Strategies for Saving Cost and Time When Making a Change to Your Device
Event Type: Sponsored Sessions
Material supplier and specification changes during initial and re-assessment of design verification biocompatibility activities can present an additional hurdle for manufacturers, which can result in costly and time-consuming retesting. In this presentation, we discuss how to evaluate biocompatibility material equivalence through leveraging physical and chemical characterization strategies. We incorporate ISO 10993-19 physical, morphological, and topographical (PMT) characterization to reduce the burden of retesting while ensuring enough information to evaluate device safety. Further, we will explain approaches leveraging targeted chemical characterization for equivalency and toxicological risk assessment of extractable chemicals.
