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Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Human Health and Performance, especially in Extreme Environments
Expert graduated in 2002. After working as a freelance outdoor instructor and completing a six month worldwide climbing expedition, Expert gained his PhD in Clinical Exercise Physiology from Employer in 2006. His PhD had a particular focus on body composition…
Cardiovascular Disease (Cardiology), Interventional Cardiology, Peripheral Vascular Disease
Associate with Employer in Roanoke, Virginia and Associate Clinical Professor of Medicine at Duke University. Former partner with Centre Medical and Surgical Associates, PC and Clinical Assistant Professor of Medicine at the Penn State Milton S. Hershey Medical Center. Initiated…
Medical Devices; Product Development, Manufacturing, Marketing, Business Practices, Intellectual Property, Commercial Contracts, Corporate Finance, M&A
Global leader and serial entrepreneur in the medical device industry with multiple successes in building companies, teams, products, and revenues. Experienced at bringing new products to the world market in a high-growth dynamic environment. Experienced Board member and Chairman in…
Cardiology, Interventional Cardiology
Expert is a general cardiologist covering all aspects of cardiology and has a specialist interest in interventional cardiology
Cardiology; Arrhythmias, Coronary Artery Disease, Congestive Heart Failure, Atrial Fibrillation
Expert is a Mayo Clinic and Harvard Fellowship Trained non-invasive Cardiologist who is engaged in practice of General Cardiology. He has been in practice for 10 years. 100% of his time is devoted to patient care and as such has…
Diagnostic Radiology, Pediatrics
Expert is Board Certified in Pediatrics, Pediatric Cardiology, and Diagnostic Radiology. Expert obtained his undergraduate degree with honors from Williams College and then proceeded to complete Medical School at the Duke University School of Medicine. expert completed his internship in…
Catheterization and Angioplasty
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; CATHETERS; CARDIOVASCULAR SYSTEM; EMBOLISMS; CARDIAC CATHETERIZATION. Expert (Expert) has over 30 years of experience performing angioplasties. He has conducted angioplasty research, including the comparative benefits of coronary angioplasty versus bypass surgery. He has also been a consultant…
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;…