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Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Batteries and Battery Interfaces: System Design and Analysis
Expert has a great deal of experience in failure analysis of various battery systems including lithium, lithium-ion, lithium-polymer, and various other nonaqueous and aqueous based systems, both primary and secondary. He is the sole battery safety instructor for NASA and…
Medical Devices – ENT Devices, Surgical Devices, Cardiac Devices, Renal Devices & Artificial Organ
Expert has over twenty years experience in designing and developing medical device to clinical problems. Also, he has extensive experience as a surgeon having performed ENT head and neck surgeries and assisted in neuro surgeries and other general surgeries. He…
Cardiac Electrophysiology, Cardiology Drugs, Pacemakers, Defibrillators, Cardiac Medical Devices
Expert. Expert is a board certified cardiac electrophysiologist (cardiologist with expertise in the diagnosis and treatment of all cardiac rhythm disorders) with over 20 years experience as a clinical investigator, IRB Chair, and high volume implanter of cardiac rhythm devices.…
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
Injury Biomechanics (head and spine), Medical Device Design, Structural Analysis, Patents
Expert has over 30 years of experience in structural analysis, including experience porting finite element codes to specialized architectures, developing special-purpose mesh generation tools, and assessing the correspondence of structural models with experimental measurements. Expert has developed de novo programs…
New Product Conception and Innovation, Industrial Design, Brand Strategies, Hand Tools, Housewares
Expert has turned major corporations around through organic growth with consumer product design and innovation. At Black & Decker he grew new product sales From $430M in 1984 to $850M in 1990. His product designs at The Stanley Works grew…
Development and Assurance of High-Assurance / Safety-Critical Software & Embedded Systems
Expert has substantial experience with software safety and reliability. Most of his career has been spent working with high-assurance systems and safety-critical software. He has developed software for commercial aviation systems, for medical devices, and for industrial controls and safety…