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Biomaterials and Product Development R&D for Orthopedic, Cardiovascular, and Other Implants
Expert has helped assemble, and been lead author on 510(k) and IDE applications to the FDA. This has often included telephone conversations, and occasionally personal visits, with the FDA to discuss unique aspects of the devices and/or materials in the…
Laboratory Medicine, Pathology
Expert is experienced in the application of basic sciences to clinical and biomedical problems. Most recently, his interests have centered on infectious diseases, concentrating on pathogen-host interactions and biomaterials with special emphasis on biocompatibility. Expert's laboratory has recently elucidated the…
Medical Technology
A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination products. Expert is proficient in total quality systems requirements…