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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…
Mechanical Design – Kinematics
Expert has published numerous papers and several books on computer-aided mechanism design, concentrating on linkage type mechanisms. He has worked on over 50 applications of mechanisms, including consumer products, automation equipment, and specialty machines. Expert is co-developer of the LINCAGES…
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…
X-Ray Imaging
Expert is the inventor, designer, and project scientist/program manager of a number of different X-ray imaging systems, ranging from satellite-based X-ray telescopes to large systems for nondestructive imaging of 50 ton rocket motors and nuclear pressure vessels. Expert has both…
Theoretical Physics, Acoustics, SONAR, Signal Processing, Piezoelectric
Expert has studied theoretical acoustics for the past 20 years. His work is strongly mathematical, extending beyond the wave equation to non-linear acoustics and propagation and to noise and even temperature. His work applies to a very wide range of…
Bar Coding, Automatic Identification, Printing, and Optics
Expert has spent many years designing and building bar code equipment and consulting on bar code technology. He has consulted on retail, shipping, medical, manufacturing, electronics, and other industrial and commercial bar coding applications. Over the last 15 years, Expert…
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…