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Medical Device and Product Development Expert
Expert is a seasoned Engineering Leader with over 20 years of experience in Medical Devices, including Product Development and Product Management. He set up the Global Technology Centre for TE Connectivity and Medtronic in India and has established a Catheter…
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 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…
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,…
Product Design and Development; Plastic Part Design and Molding; Expert Witness, Patents
Expert has managed engineering and design consulting businesses since 1976. He has served clients in fields ranging from aerospace to sanitary services to medical monitoring and instrumentation. He has utilized his extensive experience in engineering, product development, manufacturing and aesthetics…
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…
Medical Devices, Patent Strategy, Patentability, Intellectual Property, Litigation Support
She has served as Vice President of Intellectual Property & Legal Affairs for The Sharper Image Corporation. In addition to focusing on patent strategy in several positions, she has lead and built R&D teams in both Class III medical device…
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…
Medical Device Design and Manufacture
Expert has over 25 years experience in the conception, design, and manufacture of medical devices. Experience ranges from high volume disposables to low volume implantables. Beginning as a manufacturing engineer responsible for all facets of device development and manufacture Expert…
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…