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Biomedical Engineering, Manufacturing Engineering, R&D
Expert has over 20 years of experience in the research and development of medical devices for: electrodes for transcutaneous sensing and stimulation (EKG, EEG, EMG, TENS, defibrillation, pacing); respiratory therapy, specifically spirometric measurements, exercizers, and nebulizers; thermometry for clinical applications;…
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;…
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…