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Microcontamination Control
Expert (prefers Expert ) has been involved with pure, distilled, and demineralized water analysis and methods of purification for over 20 years. With a broad knowledge base and many accomplishments, he has been involved in developing and publishing most of…
CAD/CAM
Throughout his professional career Expert has both been a member and an active contributor to several professional associations, beginning in 1962 with a student membership in the Society of Manufacturing Engineers (SME). He also became a member of the Computer…
Surface Mount Technology (SMT) and High-Technology Light Sources, Turnkey Operations, etc.
Expert has devoted a significant portion of his career to the development of Surface Mount Technology (SMT) devices, equipment, and processes. These include: placement, cleaning, solder reflow equipment, components, component design, component packaging for automatic placement, and processing of the…
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.…
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…
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…
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…