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Animal Models, Preclinical Testing, GLPs, Protocols, Data Capture Forms, Veterinary Medicine
Expert has a significant amount of experience with developing animal models through discussions with cross-functional groups and considerable expertise in veterinary surgery and biomechanics. He has experience with animal models for the cardiovascular, peritoneal, gastrointestinal, cutaneous, reproductive, urinary, and skeletal…
Medical Device Total Quality
FDA REGULATION. A significant portion of Expert's career has been devoted to FDA approval and regulation of medical devices, particularily those with significant risk. He is the President of a consulting company specializing in process validation, FDA/regulatory consulting, and auditing.…
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…