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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…
Machine Vision, Imaging, Image Processing
Expert is the founder and president of a leading consulting firm in machine vision. He founded his company in 1981 at the start of the machine vision revolution. He works in application development, system design, and development, business opportunities, and…
Batteries and Battery Interfaces: System Design and Analysis
Expert has a great deal of experience in failure analysis of various battery systems including lithium, lithium-ion, lithium-polymer, and various other nonaqueous and aqueous based systems, both primary and secondary. He is the sole battery safety instructor for NASA and…
Cardiac Electrophysiology, Cardiology Drugs, Pacemakers, Defibrillators, Cardiac Medical Devices
Expert. Expert is a board certified cardiac electrophysiologist (cardiologist with expertise in the diagnosis and treatment of all cardiac rhythm disorders) with over 20 years experience as a clinical investigator, IRB Chair, and high volume implanter of cardiac rhythm devices.…
Medical Devices; Product Development, Manufacturing, Marketing, Business Practices, Intellectual Property, Commercial Contracts, Corporate Finance, M&A
Global leader and serial entrepreneur in the medical device industry with multiple successes in building companies, teams, products, and revenues. Experienced at bringing new products to the world market in a high-growth dynamic environment. Experienced Board member and Chairman 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…
New Product Conception and Innovation, Industrial Design, Brand Strategies, Hand Tools, Housewares
Expert has turned major corporations around through organic growth with consumer product design and innovation. At Black & Decker he grew new product sales From $430M in 1984 to $850M in 1990. His product designs at The Stanley Works grew…
Development and Assurance of High-Assurance / Safety-Critical Software & Embedded Systems
Expert has substantial experience with software safety and reliability. Most of his career has been spent working with high-assurance systems and safety-critical software. He has developed software for commercial aviation systems, for medical devices, and for industrial controls and safety…
Medical Device Quick Prototyping/CAD Design/Concepting
Expert (pronounced "munch"; ) has designed and developed a cast base for biometric scanning. This base resulted in stable dimensions and functionality when subjected to change in temperature. Scans were used for both hand and finger use. He developed a…
Electronic Reliability & On-Chip ESD Protection
Expert currently works on predicting the electric breakdown of silicon dioxide gate dielectric. He is knowledgeable of the electric breakdown characteristics of silicon and air. Additionally, he has studied the effects of electric field on the reliability of semiconductor devices.…