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Medical Device Regulatory Support, Medical Device Registration, etc.
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new product introductions. A committed professional…
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Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due diligence, outsourcing, and FDA regulatory matters, including consulting for…
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Safety Management in Industry and Construction
At Abbott Laboratories (Ireland) Expert A. Expert served as the chief technical resource for the sterilization of medical devices by ionizing radiation (gamma) and ethylene oxide (EO). He was directly responsible for certification and validation of a number of gamma…
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Medical Polymer Sterilization
MEDICAL POLYMER SELECTION; MEDICAL POLYMER STERILIZATION. With knowledge of material selection for medical devices, Expert has specific expertise in selecting materials based on cost, physical properties, radiation or other forms of sterilization, blood and tissue compatibility, permeability, and aging properties.…
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Sterilization, Biomaterials, Tissue Banking, Medical Product Development, Polymer Toxicology
Expert K. Expert has spent 30 years in the medical products business, in which he developed sterilization processes such as ethylene oxide, gamma radiation, vapor phase hydrogen peroxide, plasma sterilization, aseptic processing, disinfection with formaldehyde, glutaraldehyde, and steam sterilization. Novel…