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Expert in Medical Device Business Development, Clinical Trials and Regulatory Strategy, Cardiology, Cardiac Electrophysiology
As a board certified electrophysiologist, Expert has extensive experience implanting and evaluating pacemakers. In addition, she was responsible for regulating pacemakers while at the FDA. Several of her publications are in the area of pacemakers. She is a board certified…
Expert in 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…
Expert in 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.…
Expert in Cardiac Surgery, Heart Transplant, Coronary Artery Bypass, Valves, atrial fibrillation, LVAD
Expert is a cardiothoracic surgeon. He has expertise in coronary artery bypass grafting (CABG), mitral valve repair/replacement, aortic valve replacement, aortic aneurysm repair, surgical treatment of heart failure with cardiac transplantation and left ventricular assist devices (LVADs) for Bridge To…
Expert in 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…
Expert in Electrochemical Engineering, Battery, Plating, Electroforming, MEMS, Nanotechnolody, Water treatment
Expert has experience and proven success record of design and implementation products and processes in electrochemical and chemical engineering for medicine, manufacturing, and others. He is as the consulting for several medical devices companies help them in designing their products,…
Expert in Medical Devices; Product Development, Manufacturing, Marketing, Business Practices, Intellectual Property, Commercial Contracts, Corporate Finance, M&A
Expert has been the CEO or chairman of seven medical device companies in four countries - four public, three private, and has been a member of the Board of Directors of 10 companies. He is an expert in areas of…
Expert in International and Domestic Medical Devices, Sales/Distribution, QA/RA Compliance
Expert thrives on overcoming the quality and regulatory hurdles in the most time-efficient and cost-effective manner possible. He speaks fluent FDA, MDD and ISO 13485 and can converse successfully in CMDCAS, PAL, TGA, SFDA and KFDA as well. Whether you're…
Expert in Implantable and Non-Implantable Medical Device Risk, Safety, and Failures
He has experience in developing, writing, and submitting risk management related documentation to support Notified Body, 510k, PMA-S, and PMA submissions (Class I, II, and III). He has experience in the legal and safety requirements between 510k and PMA devices…
Expert in Medical Device Research and Development
Expert has over 30 years experience in medical device design dealing with all phases of design -- brainstorming, concept design, proof of concept testing, prototyping, cost / task estimating, project planning, project management, detailed design, bench testing, troubleshooting, design verification…