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Lab Safety in Industry and Academia (Pre/Post-Sec.): Medical, Forensic, Clinical, Biotech and Pharma
Expert worked for Dow Chemical Company's Lab overseas as a process research chemist. During his time with Dow, he was engrained in his work and lab safety activities. President of organization that provides advice on regulatory compliance, facilities design safety…
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…
Clinical Trials, Drug Development, Medical Monitoring, AIDS, FDA Regulation, Safety Assessment
Expert is a public health professional who has extensive international and domestic experience. She has worked for pharmaceutical/biotech companies, hospitals, public health institutions, non-profit organizations, in the areas of clinical trials design and management, community-based research, educational programs’ development and…
Medical Device Software, Safety Critical Systems, Embedded Systems Design
Expert managed the Electrical Engineering department of a consulting company specializing in medical device design. He has designed software, firmware and hardware for medical devices including a Proton Beam Radiotherapy system, blood infusion pumps, blood analyzers, hysterscopic pump, drug scanning…
Pharma-BioTech Clinical Trial Development and Drug Safety, Medical Monitor
Dr. received her M.D. degree from the University of Utah School of Medicine in 1988. She then completed training to practice in remote rural communities through a program at the McKay Dee Hospital for three years as a board certified…
Plastic Surgery, Patient Safety and Accreditation, Risk Mgt, Medical-legal evaluations and reviews
Thirty-six years in the private practice of Plastic and Reconstructive Surgery have afforded Expert multiple levels of expertise in both medicine and business. Cosmetic and reconstructive surgery of the face is a hallmark of today's plastic surgeon. Years of training…
General Surgery, Rural Healthcare; Patient Safety and Medical Malpractice
Expert has 30 years of experience as a general surgeon in Colorado. He is Board Certified in Surgery with additional qualification in Surgical Critical Care. He practices in both an urban Trauma Center and a rural critical access facility, providing…
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…
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…
Clinical Trial, Biomarker, Clinical Development, Drug Safety, Medical Affairs, Commercialization
As a prescribing physician and a physician in drug development for many years, Expert has expertise in drug mechanism of action and clinical data, and clinical use. Expert is an expert in drug clinical development from planning to protocol design,…