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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.…
Metal Can Manufacturing and Filling Problems, Printing, Anilox Rolls, Inks & Coatings, etc.
Expert has over 20 years of experience in the metal container industry with specific emphasis in can manufacturing, R&D, interior and exterior can coatings, can evaluation, cost reduction analysis, chemical/ physical testing of can components and canned products, and can…
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;…
Forestry, Soil, environmental (atmospheric) pollution
Expert (pronounced greegle) considers himself to be a forest ecologist, with an emphasis on the effects of disturbances on forests. Many of the disturbances which effect forests are related to humans, such as air pollution (acid rain and ozone) and…
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…
MS Windows engineering, C++
Expert (rhymes with easy, ) has been writing MS-Windows applications since before the release of Windows 1.0 (1985). His clients have included Lotus, Digital Equipment Corp., Waters-Millipore, Aspen Technologies, and Polaroid as well as several smaller companies in the Boston…
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…
Institutional Technology, Information Technology Applications, Information Technology used in Europe
COMPUTER-ASSISTED TEACHING. As Dean of the College at Employer from 1978 through 1985, Expert supervised and guided a nationally significant effort to incorporate computers and networking technology into educational programs of engineers and scientists. Since 1988, he has directed a…
Molecular Biology, Molecular Pathology, Polymerase Chain Reaction Technology
Expert has expertise in the adaptation and development of molecular biological techniques to answer medical questions of human genetics, differential gene expression, diagnostics, epidemiology, and pathogenesis, particularly in regard to infectious agents and genetic diseases. The CGS is a multidisciplinary…
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…