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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.…
Molecular Biology and Medicine; mitochondrial disease; genomics
Expert is an expert in the use of electrophoresis, PCR, and other DNA analyses. He has also been cloning and analyzing nuclear genes that are part of the cytochrome oxidase complex -- he has examined their structure, function, and molecular…
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…
Electrical and Biomedical Engineering, Patent Analysis, Medical Devices, Electrical Trauma
Expert is an expert in electrical fire investigation; patent infringement and analysis; devices and instrumentation; electrical and medical device testing including artificial cardiac pacemakers; industrial accidents; electrical power systems; medical implants; sports injuries; product safety and design deficiencies; electrical and…
Adhesives and Sealants
Throughout his career, Expert has focused his work on high-performance thermoplastic and thermosetting adhesives and sealants for the bonding and sealing of metals, plastics, and glass. Expert is an international authority on the synthesis and application of "instant adhesives" ("super…
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…
Exercise Physiology Nutrition
EXERCISE PHYSIOLOGY. Expert is an expert in the bodily responses of people to exercise. He is extremely knowledgeable about the physiological factors which limit or determine a person's ability to exercise. He has studied a wide variety of people ranging…
Innovation Methodologies, Processes and Tools Training & Certification; Innovative Problem-Solution Coach/Consultant using: FMEA, FH-Decomp, MVIS & PDS-G
Expert in: Innovation Methodologies & Tools Innovation Coach/Consultant and Certification Training Systems Reliability & DfR DFSS-Black Belt, Failure Mode Effects Analysis, FMEA, DFMEA, PFMEA, FMECA, FTA, FH-Decomposition Innovative Rapid System Problem Solving Expert developed PDD, Principle Driven Development to help…
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…
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…