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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;…
Biomass Power Generation Technology and Engineering: Design, Construction and Operations
Expert has expertise in multiple forms of energy generation, including steam boilers and gas turbine prime movers. He also has experience with gas and fuel oil reciprocating engine generators and small-head hydroelectric facilities. He is expert in the utility and…
Underwater Structural Inspection
Expert specializes in nondestructive testing (NDT) inspection of American Bureau of Shipping and United States Coast Guard surveys for underwater inspection in lieu of drydocking. He writes procedures, administers qualifications, and has conducted several research studies on various NDT techniques…
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…
Instrumentation: Project Management, Marketing, and Sales
Expert has spent 25 years in instrumentation, dealing with the end instruments listed next to this paragraph. He has designed, improved, and used all of these in all types of applications. He lays emphasis on reliable use, even under unique…
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…
Uses of Polymers, plastics, silver and other metals. EPA regulatory processes
For the past 25 years, expert has been actively involved in all phases of medical plastics synthesis, processing, and use. His experience includes custom formulation of polymers, analysis of medical markets, and selection of materials that will withstand the various…
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…
Geomechanics and Material Testing
Expert has applied numerical methods and constitutive models for a wide range of soil-structure interaction problems. He has in-depth knowledge of rock mechanics, soil mechanics, and groundwater flow modeling. His knowledge of geotechnical engineering allows him to answer complex questions…