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Expert ID: 108074 California, USA

Expert in 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;…

Expert ID: 107897 South Dakota, USA

Expert in 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.…

Expert ID: 713381 Minnesota, USA

Expert in 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…

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