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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.…
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…
Microelectronics Processing and Contamination Control, Cleanrooms, Particulates, Ultra High Purity
Expert has twenty years of research experience in semiconductor technology in major industrial laboratories. This, combined with his expertise gained by fifteen years managing microelectronics laboratories where he performed semiconductor fabrication research at two major universities (Minnesota and Arizona), makes…
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…
Motion & Numerical Control, both Technical & Market Research Capability
Expert has worked with CNCs for over 35 years. He has led a design team on CNC and done sales and marketing of CNCs. Expert has also completed several CNC market research studies. Expert has a master's degree in servomechanisms…
Advanced PC Systems Design
Expert has focused his research and practice for the last several years on the design and implementation of PC-based office productivity systems. He has placed special emphasis on user interface design, decision support systems, and executive information systems. Expert is…
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…