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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,…
Neurotechnology, Brain-Computer Interfaces, Neurological and Neurosurgical Medical Devices
Dr. is a Neurologist and Translational Neuroscientist at Employer since July 2011. He was a Neurologist and Translational Neuroscientist at the University of Pennsylvania, a position he has held from July 2010 to June 2011. Dr. earned the MD and…
Accident Reconstruction, Biomechanical, Mechanical, and Neuroelectrical Medical Device Engineering.
Expert understands brain, spinal and orthopedic biomechanics and has analyzed hundreds of cases to determine the causation of injuries sustained by drivers, workers and citizens. He has performed biomechanical research using cadaveric models to understand the kinematic behavior of joints,…
Orthopaedic Surgery; Spine; Total Joints; Sports medicine; Tumors, Rehabilitation, and Trauma.
As an orthopaedic surgeon in private practice and as an attending faculty member at several academic institutions, Expert has a great deal of clinical and surgical expertise in the areas of expertise as listed. Served as consultant and Medical Director…
Disorders of the Spine: Trauma, Degenerative Conditions, Tumors, Infections, Surgery
Expert is a board-certified internationally respected orthopedic surgeon with over 33 years of clinical experience as a spine specialist, treating common and complex spinal disorders. He received his medical degree and orthopedic training at the University of Toronto in Canada,…
Medical Device Design and Manufacturing, Measurement Systems, Embedded Systems, etc.
Expert has extensive experience with biomedical imaging and medical diagnostic imaging as listed below: • Cell Counting – Used segmentation, clustering and classification techniques to count cells in fluorescent and scatter images. • DR Bone Densitometry – Developed automatic and…
Biomaterials and Product Development R&D for Orthopedic, Cardiovascular, and Other Implants
Expert has helped assemble, and been lead author on 510(k) and IDE applications to the FDA. This has often included telephone conversations, and occasionally personal visits, with the FDA to discuss unique aspects of the devices and/or materials in the…