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Medical Device Regulatory Affairs: CE (Canada) and FDA
Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…
Vascular Surgery
Expert has extensive experience in vascular surgery, including arterial reconstructions for lower limb ischaemia, aortic and peripheral aneuryms and carotid endarterectomy. He also has expertise in treating the diabetic foot, including amputations, and in varicose veins and in venous thromboembolism.
Anesthesia, Pharmacoeconomics, Cost Effectiveness, PONV, OR Management, Practice Guidelines
Expert is the chair at the largest anesthesia training program in the world. His dept has a direct 50MM budget, performs 80,000 anesthetics annually (most high risk), covers 10 facilities, > 100 anesthetizing sites daily, and has500 personnel in the…
Vascular and Endovascular Surgery
Expert has performed over 500 aortic reconstructions including all procedures and conditions listed above. Mortality for elective cases (not including ruptured aneurysms) is less than 1%. Expert has performed over 2,000 interventional cath lab procedures using all procedures listed above…
Cardiac, Thoracic, Vascular and Geriatric Anesthesia
Expert is cardio-thoracic-vascular anesthesiologist with expertise in present clinical practice, including basic cardiac patients, repair of aortic aneurysm, heart transplant and ventricular assist devices. He is board cetrified, teaching residents and fellows. His clinical research obtain work and publications about…
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…
Medical Device Product Development; Machine Design; Biomedical Engineering
Medical device product development engineer. He performed research on adding an antimicrobial agent to a silicone rubber medical device molded using LIM. The research included materials, methods of molding, color changes, and effects on biocompatibility. His library contains many materials…