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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…
Data Management, Self-Service Quality Data
Coming from Pekin Insurance where she was an Assistant Vice President for four years modernizing their data platforms and operations, Expert is now Chief Data Officer for one of the US states. Prior to that she was the Enterprise Information…
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,…
Cardiology, Interventional Cardiology
Expert is a general cardiologist covering all aspects of cardiology and has a specialist interest in interventional cardiology
Interventional Cardiology, Percutaneous Left Ventricular Assist Devices
Expert graduated from John Hopkins University School of Medicine and trained in internal medicine. He completed his fellowships in cardiology and interventionalcardiology and currently works as the Director of the Adult Cardiac Catheterization Laboratory at his afiliated university. He also…
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…
Medical Device Regulatory Submissions
She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems and Catheters; Surgical, Ophthalmic…
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…