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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 Failure Analysis, Medical Device Product Liability, Patent Infringement Analysis, Patent Invalidity and Validity Analysis, Patent Claim Construction
Expert has over 20 years in the medical device and electronics industries, with contributions exemplified in the numerous products that were developed under his leadership. These products today are improving the quality of healthcare, in hospitals, sub-acute and alternate care…
Healthcare Strategy, Technology & Innovation
Expert has 20+ years of experience in the healthcare industry. He is currently a Principal at a healthcare consultancy focused on health care strategy, technology, and innovation. He offers advising services like topic-specific research, environmental/market assessments, strategic planning, operations/workflows design…
Microelectronic components materials and reliability
Expert has 31 years of experience (the most recent 12 years in the position of Senior Scientist responsible for company analytical laboratories) at three companies manufacturing advanced semiconductor devices for military, aerospace, medical device, and other applications, and an additional…
Failure Analysis for Glass, Porcelain, and Metals; Accident Reconstruction
Expert possesses over 25 years' consulting experience pertaining to metallurgy, materials, accident reconstruction, product liability, OSHA worker safety, intellectual property, factory safety and other related fields. In this capacity, his client base has primarily been comprised of attorneys, and his…
Plasma Physics and Pulsed Power
Expert has a Ph.D and over 10 years' experience in the analysis, design, commissioning and operation of large power and control systems associated with plasma physics experiments. His experience includes DC and pulsed power systems, high-voltage and high-current systems, and…
Medical Devices, Pharmaceuticals, CMC, Regulatory Affairs, R&D, Design Controls, Autoinjectors, Syringes, and Manufacturing
Expert has extensive experience in Pharmaceutical and Medical Device industry. He managed multiple departments and spearheaded combination product activities to launch products. This included FDA/EMA meetings, Human Factor activities, Device Design and Development, Regulatory submissions, and Manufacturing responsibilities. He has…
Medical Devices
Expert has about 10 publications on ablation. He published papers on this area and had grants to develop radio-frequency cardiac and liver ablation systems. He founded and directed a laboratory for medical device testing under IEC standards. Overview of Skills:…
Biostatistics, Statistics, Programming, and Epidemiology
This expert is a Harvard PhD graduate and currently Associate Professor of Biostatistics at a U.S. university, where her position is tenured. Her biostatistical and statistical research and teaching includes applications Immunology and Infectious Diseases; Pathology; Epidemiology; Anesthesiology, Perioperative, and…
Intellectual Property, Patents, and Medical Devices
Expert is an award-winning, Oxford-educated scientist with expertise in electronics, medical imaging, medical devices, sensors, semiconductors, MEMS, image processing, and signal processing. He has been deposed in a patent case. His experience spans a variety of industries and applications, including…