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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 Innovative Devices, Optics
Expert applied his physics background to understand tension-free hernia repair. He along with his surgeon colleagues proposed new methodology in development of meshes. He quantified the effect of abdominal forces on the implant and proposed a novel mesh. This novel…
Medical Device Regulatory Support, Medical Device Registration, etc.
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new product introductions. A committed professional…
Overseas Sourcing of Components & Finished Goods, Electronics, Plastics, Fortune 1000 Companies
He has managed projects for an access control company and have supplied 2-3 different companies with access control products manufactured in China. Has sourced and managed several projects for companies in the CE audio field with volumes exceeding $5 million…
Medical/Hospital Equipment: Markets, Unmet Needs, Concept, Design, IP, Automation, Manufacturing
Biomedical Devices range from simple items we use as consumers to complex instruments controlled by proficiently trained professionals. Expert's involvement and experience has been in the development of capital equipment that often included one or more disposables, were used 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…
Quality System & Regulatory Compliance, Life Sciences, Re-Engineering, 21 CFR Part 11
Business system design, business process re-engineering, and business re-engineering are at the core of the expertise she offers her clients. She has designed, written, and implemented business-focused quality systems for start-up companies and well as provided re-engineering support for out…
Healthcare IT Sales, Hospital Quality and Risk Management Software, and Healthcare Reform Software
Expert's specific experience with implantable devices comes from selling Orthopedic implants, in particular, total joints like hips and knees, and trauma devices in the Operating Room. Other products include Osteobiologics like pig skin for soft tissue repair. He facilitated over…
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…