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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…
Nanobiotechnology, Drug Delivery Platforms, Medical Devices, Targeted Therapeutics, Diagnostics
Expert has extensive experience establishing R&D operations in early stage biotechnology companies. He applied his knowledge in nano(bio)technology to develop innovative solutions to drug delivery and drug targeting challenges. His efforts to enhance the use of biomaterials in a variety…
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…
Medical Devices, In Vitro Diagnostics Design, Quality Control, Trouble-Shooting, etc.
Expert has authored and submitted 510(Experts for more than 25 IVD (In Vitro Diagnostics) products. These 510(Experts encompass a variety of IVD products from manual, semi-automated to fully automated non-isotopic diagnostic tests including point-of-care devices. Expert has the expertise to…
Otolaryngology: Surgery & Management; Medical Device and Software Design- Lasers & Robotics
Expert P. Expert, MD is currently Director of Otolaryngology & Communicative Disorders at North Shore University Hospital, a component of the North Shore - Long Island Jewish Medical Center. He is also a Director and Founder of the Laboratory of…
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…
Commercialization of Scientific Devices, Inventions, Scientific Management Consulting, etc.
Expert has used his experience and knowledge of biochemistry and biophysical measurement to create tools for measurement of clinically significant targets for the biomedical industry. He has developed Drugs of Abuse and many other assays, supported the development of complex…
Personalized Medicine, Genomics, Proteomics, Bioinformatics, Oncology, Biotechnology, IBD
As the director of the Employer Genomics and Proteomics Center and of the Dana Farber/ Harvard Cancer Center Proteomics Core, Expert has ample expertise in bioinformatics, since each of these facilities includes a whole core for bioinformatics. Expert supevises a…
Computer Forensics, Electronic Discovery, Internet Crimes and IP/Patent Analysis.
Expert has used BASIC on many computing platforms. He has designed, developed and implemented many batch programming languages. Representative computer science and engineering courses include: management information systems programming in Pascal, Cobol, Basic, Fortran, and C and C++ Programming. Engineering…