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Sterilization, Biomaterials, Tissue Banking, Medical Product Development, Polymer Toxicology
Expert K. Expert has spent 30 years in the medical products business, in which he developed sterilization processes such as ethylene oxide, gamma radiation, vapor phase hydrogen peroxide, plasma sterilization, aseptic processing, disinfection with formaldehyde, glutaraldehyde, and steam sterilization. Novel…
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)…
Friction and Wear Reduction, Biomechanics
Expert is a specialist in tribology. His primary expertise is in friction and its consequences during dry sliding of mechanical components. Specific topics of his activity include the measurement of friction coefficients during dry sliding of polymers and ceramics against…
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.…
Auditory Bioengineering, Sensory Aids, Hearing Loss, Passive & Active Protectors
Expert's main expertise lies in applying the combination of hearing science, audiology, and electrical engineering to the functional design of devices for the normal or impaired ear. This includes research on speech processing to improve understanding by the hearing impaired;…
Biomedical Metals Technology
PRODUCT DEVELOPMENT CYCLE TIME. Expert has focused a significant portion of his career on product development manipulation. This has involved reducing the cycle time from concept to product introduction. He has applied this experience to a variety of scientific disciplines.…
Electrical and Biomedical Engineering, Patent Analysis, Medical Devices, Electrical Trauma
Expert is an expert in electrical fire investigation; patent infringement and analysis; devices and instrumentation; electrical and medical device testing including artificial cardiac pacemakers; industrial accidents; electrical power systems; medical implants; sports injuries; product safety and design deficiencies; electrical and…
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…