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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,…
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…
Molecular Psychiatry and Neuroscience, Neuropharmacology, Cancer Immunotherapy
Expert has combined his extensive expertise in molecular biology, immunology, molecular neuroscience and psychiatry, and cancer biology to develop a new avenue in the discovery of suitable molecular targets for complex treatment of neurodevelopmental disorders (e.g. ADHD). The new treatment…
Cardiovascular Research, Pharmacology, Toxicology, Pathology, Expert witness consulting
Expert obtained a BSc in Biochemistry from Carleton University in Ottawa and a PhD in Medical Sciences for studies conducted with Expert Richard Haslam at McMaster University in Hamilton, Canada. After graduation, he carried out Medical Research Council of Canada-funded…
Flow Cytometry
Expert has been in the lab over 20 years focusing in oncology and immunology. She has been involved in assay development utilizing ELISAs, Westerns, ELISpot and flow cytometry to forward multiple research projects. Her area of expertise is in flow…
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…
Medical Device Design Control and Software Validation
Expert has extensive medical device engineering development and regulatory experience. He is a certified Lloyds of London ISO 9000 Lead Auditor and a member of the Westlaw Roundtable Expert Witness Network. His regulatory experience is primarily in product development, design…
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…
Exercise Physiology, Fitness, Skeletal Muscle, Physiology, Thermoregulation, and Environmental Stress
The combination of Expert's experiences in basic and applied science, human, animal and clinical subjects, industry and academia, cellular biology and exercise physiology, in vivo and in vitro techniques, and teaching and research make her a uniquely qualified scientist. She…
Cardiovascular Disease (Cardiology), Interventional Cardiology, Peripheral Vascular Disease
Associate with Employer in Roanoke, Virginia and Associate Clinical Professor of Medicine at Duke University. Former partner with Centre Medical and Surgical Associates, PC and Clinical Assistant Professor of Medicine at the Penn State Milton S. Hershey Medical Center. Initiated…