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Dielectric Phenomena
Some of Expert's prior work has centered on the design and appraisal of transformer insulation structures, with particular emphasis on oil/cellulose systems. This work has involved both fundamental research on mechanistic aspects and the implications for design. He has been…
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…
Biomedical Engineering, Manufacturing Engineering, R&D
Expert has over 20 years of experience in the research and development of medical devices for: electrodes for transcutaneous sensing and stimulation (EKG, EEG, EMG, TENS, defibrillation, pacing); respiratory therapy, specifically spirometric measurements, exercizers, and nebulizers; thermometry for clinical applications;…
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.…
Information Management
Expert has had over 30 years of experience in the laboratory environment. Prior to starting his independent consulting practice in 1985, he was employed in industry. He has been actively engaged in the use of computers for the management of…
Metallurgical Engineering
Expert has expertise in the selection and application of materials, including metals and ceramics. He has been responsible for material selections for aircraft jet engines, industrial gas turbines, steam turbines, and generator components for 35 years. This includes the statistical…
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…
Gastroenterology, Medical Use of Voice Recognition
A leading expert on the evaluation of medical lexicons, Expert is the American representative to the international group developing the minimal standard terminology to digestive endoscopy and has a major grant to test it in the U.S. The National Library…
X-Ray Imaging
Expert is the inventor, designer, and project scientist/program manager of a number of different X-ray imaging systems, ranging from satellite-based X-ray telescopes to large systems for nondestructive imaging of 50 ton rocket motors and nuclear pressure vessels. Expert has both…