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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…
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…
Failure Analysis of Materials
MATERIAL FAILURE ANALYSIS; ADHESIVE FAILURE; COMPOSITE FAILURE; METAL FAILURE. Expert's (pronounced Wall-teen) principal occupation has been in the analysis of failures of machine components, including orthopedic (surgical) implants. Materials analyzed include metals and alloys of all types, polymers, elastomers, composites,…
Biomedical Device Engineering
BIOMEDICAL PRODUCT DEVELOPMENT; MEDICAL DEVICE PRODUCT DEVELOPMENT; NEW PRODUCT DEVELOPMENT. Expert has dedicated his career to the research, design, development, engineering, and manufacturing of biomedical devices and instruments. Expert has directed medical device new product development projects and a product…
Blood Wetted Devices and Biomaterials
BLOOD-WETTED BIOMATERIAL; CARDIOVASCULAR PROSTHESES; ARTIFICIAL INTERNAL ORGANS. Expert has been involved in the design, development, and evaluation of extracorporeal and implantable artificial internal organs for many years, first with the artificial kidney (including hemodialyzers and those based upon selective absorption)…
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…