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hi Iamp;#39;m Dr Anna faf and Iamp;#39;m an analytical scientist on the medical device extractables and leachable teams at eag labs in St Louis and today Iamp;#39;m going to tell you how to turn on easy mode for the identification stage of your next enl study our team performs chemical characterization of medical devices ing to ISO 10993 part 18 guidelines we identify chemicals extracted from a device that might end up in a patientamp;#39;s body and the potential worst case quantities the patient might be exposed to while they use the device these identifications are essential for a toxicological risk assessment later on which is a major step on the way to getting the device approved I specialize in liquid chromatography high resolution Mass spectrometry highres lcms which is an extremely powerful analytical technique that yields a wealth of information I can use to pinpoint which compounds are present in your test article extract and at what concentration using this technique I ca
