RTS Archive: Using Chemical Characterization for Material Equivalency
by Darin Kent
Medical Research Toxicologist, NAMSA
Wednesday, April 16, 2014 11:30 AM - 12:30 PM (Eastern Time)
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“Change is inevitable…..” In the medical device industry this is the rule, not the exception. Given that changes in the availability of raw materials, manufacturing processes, packaging, sterilization, etc. are going to happen, how can device companies detect, manage, and minimize the impact of these changes? One of the fundamental tenets of the ISO10993-18 – Biological Evaluation of Medical Devices, Part 18: Chemical Characterization of Materials standard is establishment of chemical, and potentially toxicological, equivalence. Proper implementation of these techniques can avoid unnecessary biological testing. This talk will describe how to use chemical characterization techniques to examine the equivalency of materials and medical devices to minimize the cost, in terms of both money and time, of changes introduced into medical devices.