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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…
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.…
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.…
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…
Laboratory Medicine, Pathology
Expert is experienced in the application of basic sciences to clinical and biomedical problems. Most recently, his interests have centered on infectious diseases, concentrating on pathogen-host interactions and biomaterials with special emphasis on biocompatibility. Expert's laboratory has recently elucidated the…
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…
Workplace Safety, Product Safety, Mechanical Engineering, Workplace and Product Safety Surveys
Expert has expertise in product safety and liability reduction and specializes in electro-mechanical and mechanical systems. He has extensive experience in the areas of compressed gas systems, firearms, chainsaws, agricultural equipment, ladders, punch presses, power shears, power breaks, metal working…
Business Strategies
Strategic Planning; Project Planning; Performance Measurements; Balanced Scorecard: Expert has extensive experience in strategic planning, and C-level team facilitation. He has conducted strategic business planning for manufacturing, construction, publishing, distribution, and service industries. He has been involved with formulating mission…