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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.…
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…
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…
Computer Systems, System Programming, Digital Forensics, Computer Scientist
Expert earned his Ph.D. from the Graduate Center of the City University of New York (2018). He received his B.A. (1981) and M.S. (1983) degrees from New York University in computer science. His work involves the design, implementation, and use…
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…
Hydraulic and Hydrologic Engineering
Expert has over 40 years of experience in water resources planning, development, and management. His experience includes: planning; conceptual design; development of plans and specifications; construction and functional operation of flood control; and navigation and multi-purpose dam and reservoir projects.…
Power Conditioning, Energy Systems
Expert research and development has been on various aspects of power conditioning, motor drives, and energy storage. His advanced studies have been in electric power systems and machines, DC current interruption, normal and superconductive magnetic energy storage, switching power converters,…
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…