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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…
Project Management
Expert is the leading recognized expert on project management software. He has been responsible, either as manager or consultant, for the selection of project management software products for over four dozen organizations. He has contributed to the design and development…
Financial Economics, Information Economics & Capital Planning
Expert is proficient in the use of Monte Carlo computer simulation techniques to estimate risk in cost/benefit models and critical path networks of tasks. He has developed spreadsheet-based macrocode to generate non-uniform random variates and perform computer simulations. He is…
Network Technology and Design; Nonprofit Capacity Building and Funding Strategies
Expert has over 15 years of hands-on experience in the development, implementation, and integration of data, digital, and voice systems. Expert developed a system equipped to handle imaging, voice response, LAN, 3270, T1, and video conferencing transmission. Expert developed a…
Machinery CE-Marking, Medical Device CE-Marking, CE-Marking with EU Authorized Representative Office
ISO 9000 IMPLEMENTATION; ISO 9000 AUDITING. Expert has expertise in implementing, documenting, and auditing procedures of medium to small companies that are pursuing ISO 9000 certification. Her organization provides training and consulting to implement ISO 9000, with emphasis on minimizing…
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.…
Petroleum Refining Evaluation
Expert's company was founded as a consulting group of Registered Professional Engineers. As such, they serve clients worldwide in the energy industries, i.e. petroleum refining, natural gas processing, petrochemicals, chemicals, oil, and gas. Expert assists petroleum refining clients by applying…
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…
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…
Pesticide Toxicology, Pesticide Chemistry
Expert has conducted research in pesticide toxicology and chemistry, focused primarily on insecticides, including the chlorinated hydrocarbons (such as DDT, methoxychlor, dieldrin, and heptachlor), the pyrethroids (such as pyrethrum and many synthetic pyrethroids), organophosphates, carbamates, and natural products. His work…