Surface, interface and material characterization of medical devices are needed to test for performance and safety, and also to ensure regulatory requirements are met. This presentation reviews the analytical techniques that address these issues. Topics include Part 18, the chemical characterization of materials for ISO 10993, extractables and leachables studies, analysis for residuals on surfaces and particulate characterization. Medical device characterization techniques discussed include GC-MS, LC-MS, Ion Chromatography, ICP-MS, and more. Examples of surface characterization techniques include AFM, Auger, XPS, ToF-SIMS, XRD, XRF and more.
About the presenter:
Dr. Sankar Raman has more than 35 years of surface science analytical expertise gained from a career in both academia and industry. In his role at EAG Laboratories, Dr. Raman helps clients find solutions for challenges involving R&D, production monitoring and failures. A subject matter expert in surface analytical techniques, Dr. Raman has served as a scientist at Monsanto Chemical Company and Advanced Micro Devices before joining Physical Electronics in their technical marketing group. He earned his Ph.D. in Semiconductor Physics from the University of Bombay, followed by a post-doc at the University of Geneva.
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