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Medical or Pharmaceutical R&D and Manufacturing – New Product Approval and Launch Including FDA, EMA, and Asia
40 years in design, manufacturing, R&D, and compliance. For the last twenty years have directed and led projects leading to over thirty 510(k), PMA, and NDA approvals in drug delivery, ophthomalogy, dental, cosmetics, emergency medicine, obstetrics, oncology, and diabetes. Clients…
Cardiothoracic and Vascular Surgery, Reimbursement, Clinical Trial Design, Litigation
Clinical Associate Professor of Surgery at a major university and Director of Cardiothoracic-Vascular Surgery Research at a research institute. He is triple board certified in Cardiothoracic, Vascular, and General Surgery. Expert maintains an active clinical research department and has over…
Critical Care & Anesthesiology
Expert is a well-respected Anesthesiologist/Anesthetist and Teacher with a strong record of clinical and research experience. He is highly skilled in modern anesthesia practices, including simple and advanced airway management through Airtraq fiber optic intubation, combitube blind insertion airway device,…
Interventional Cardiology
Expert is an internationally recognized cardiologist, inventor, educator, and author. A diplomate of the American Board of Cardiovascular Diseases and the American Board of Interventional Cardiovascular Diseases, Expert is one of the early pioneers of angioplasty and is considered one…
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,…
Cardiovascular and Thoracic Surgery
Expert has over 30 years of clinical experience in cardiovascular and thoracic surgery. He is experienced in coronary artery bypass, initially performing it with cardiopulmonary bypass, but now doing over 80% "off-pump". He developed the largest beating heart surgery program…
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.
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…
Microsurgery, Reconstructive Surgery, Hand Surgery, Breast Reconstruction, Nerve Reconstruction
Expert has significant experience in all aspects of microsurgery. He has an established clinical practice in which microsurgical techniques such as nerve reconstruction, vascularized bone transplantation, replantation, toe transplantation for hand reconstruction, and soft tissue transplantation are routinely utilized for…
Medical/Surgical Device Design, Management, Marketing, Regulatory
Expert is a results-oriented professional with proven domestic and international experience in health care administration, medical devices, marketing, staff development, product development and management, luminary and customer liaison, public relations, technology assessment and transfer, intellectual property, research and development, clinical…