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Medical Device Accidents, Surgical Fires, Oxygen Safety, Medical Gas Piping, Failure Analysis
Eng. Expert has been conducting medical device accident investigations for 25 years and product failure analysis for more than 30 years. These failures sometimes involve the actual failure of a metal, plastic, or glass part or a failure of the…
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…
Microbiology, Infection, Infection Control, Occupational and Hospital Hygiene, Biohazards, and Needlestick
Expert offers a highly valued research-driven consultancy specializing in healthcare, environmental, and occupational microbiology, waste management, and bio-safety. With a strong science-based research record in these areas, and a background in NHS and University Medical Schools, he has over 35…
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…
Medical Devices
Expert is a medical device consultant and executive with more than 20 years experience in the medical device industry. His expertise spans all aspects of medical device commercialization, from medical device product development to medical device manufacturing and quality control;…
Electronics Design and Manufacture Reliability, Failure Analysis, Asia Manufacturer Risk Management
Expert has over 20 years of expanding responsibilities in the research and engineering of reliability risk identification, analysis, quantification and mitigation in the context of product and technology development. He is responsible for both technical and organizational leadership and technical…
International and Domestic Medical Devices, Sales/Distribution, QA/RA Compliance
Expert thrives on overcoming the quality and regulatory hurdles in the most time-efficient and cost-effective manner possible. He speaks fluent FDA, MDD and ISO 13485 and can converse successfully in CMDCAS, PAL, TGA, SFDA and KFDA as well. Whether you're…
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…
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…
Human Factors Engineering for Medical Devices and Software, Patient Safety
Expert has a PhD in Computer and Information Science with a major in artificial intelligence and minors in the theory of computation and cognitive science. His artificial intelligence worked included knowledge sharing and problem solving strategies for knowledge-based systems ranging…