Ann Prewett, PhD
Medical Devices, Products Liability
medical device, implant,bone graft,orthopedic, vascular grafts, collagen, biomaterials, hydrogels,FMEA,FDA, CE Mark, Design Control, ISO13485: CAPA, biocompatibility testing, spine, spine fusion, chemical analysis, chemical characterization, sterilization, ethylene oxide, wear debris, 510k
Medical device expert with PhD in Chemistry and 28 years experience. Invented and developed many successful medical products in cardiology, spine and orthopedics. Am named inventor on many patents and have represented law firms both as an expert and fact witness in deposition and at trial for product liability and patent cases. Authored/co-authored over 60 abstracts and published papers in fields spanning orthopedics, dentistry, cardiology, medical devices and spine. Have worked in all areas of product development from conception, design, design validation, design transfer, production and commercialization. Responsibilities included preclinical safety, chemical analysis, residual testing, biocompatibility ISO 10993, static/ fatigue biomechanical testing. Invented and commercialized an FDA, 510k cleared product. Invented and launched minimally invasive spine products sold in Europe under CE Mark. Wrote Clinical Evaluation Reports and biological safety for EU MDR 2017/745. Recer...
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