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Expert ID: 726245 Minnesota, USA

Expert in Implantable and Non-Implantable Medical Device Risk, Safety, and Failures

He has experience in developing, writing, and submitting risk management related documentation to support Notified Body, 510k, PMA-S, and PMA submissions (Class I, II, and III). He has experience in the legal and safety requirements between 510k and PMA devices…

Expert ID: 736123 Indiana, USA

Expert in 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…

Expert ID: 725687 Maryland, USA

Expert in Medical Device Business Development, Clinical Trials and Regulatory Strategy, Cardiology, Cardiac Electrophysiology

As a board certified electrophysiologist, Expert has extensive experience implanting and evaluating pacemakers. In addition, she was responsible for regulating pacemakers while at the FDA. Several of her publications are in the area of pacemakers. She is a board certified…

Expert ID: 734924 California, USA

Expert in Medical Device Engineering

He worked on hazard analysis of medical devices such as biochemical sensors. He worked on packaging processes of medical devices such as implantable catheters. He worked on packaging materials of medical devices such as plastic packaging. He worked on manufacturing…

Expert ID: 729236 California, USA

Expert in Medical Device Technology, Design and Manufacturing

Expert is a seasoned engineer with over 25 years of expertise in all aspects of medical device research, product and process development. His major areas of expertise include minimally invasive treatments of vascular disease as well as laparascopic and open…

Expert ID: 728254 California, USA

Expert in Rapid Development of Controlled Release Drug and Drug-Device Combination Products

Expert, Ph.D., is an independent consultant with 15+ years experience in developing controlled release implantable and injectable products for proteins/peptides and small molecule drugs, spanning from chronic/systemic delivery to acute/local delivery, with special focus on drug delivery platforms and drug-device…

Expert ID: 728017 Texas, USA

Expert in 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,…

Expert ID: 726312 Maryland, USA

Expert in Injury Biomechanics (head and spine), Medical Device Design, Structural Analysis, Patents

Expert has over 30 years of experience in structural analysis, including experience porting finite element codes to specialized architectures, developing special-purpose mesh generation tools, and assessing the correspondence of structural models with experimental measurements. Expert has developed de novo programs…

Expert ID: 726036 Minnesota, USA

Expert in Medical Device Research and Development

Expert has over 30 years experience in medical device design dealing with all phases of design -- brainstorming, concept design, proof of concept testing, prototyping, cost / task estimating, project planning, project management, detailed design, bench testing, troubleshooting, design verification…

Expert ID: 726017 Minnesota, USA

Expert in Surface Engineering, Diamond like hard coating, material science, Medical device, hard disk

Most of Expert's scientific career has been devoted to the development of surface modification and thin film deposition technologies, including plasma nitriding, plasma carbonization, boriding, chromizing, cathodic arc, filtered cathodic arc, pulsed laser ablation, magnetron sputtering, pulsed mid-frequency dc magnetron…

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