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Materials, Processes and Hermeticity Testing of Microelectronics for Aerospace and Medical Implants
He has demonstrated expertise in hermetic sealing and leak testing processes for cavity style packaged microcircuits intended for high reliability military, aerospace and Class III medical implants. He has worked as a hermeticity consultant for prominent military and aerospace companies…
Medical Devices, Biomaterials, Due Diligence, Business Development
Expert has extensive research and development expertise having spent over 20 years in the development of orthopaedic implants. This lead to over $1billion in sales. The technologies developed included calcium phosphate cement, 2 different calcium phosphate coatings, biodegradable implants and…
Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Construction Safety
Expert has over 40 years' experience in worldwide professional safety. His work experience includes tenure as Corporate Safety and Security Director for four Engineering, Design and Construction Management Firms. This work has involved over 600 worldwide construction projects. Additionally, as…
wound healing, burns, clinical research, FDA regulations, drugs, devices, medical writing
Expert provides scientific knowledge and regulatory background to assist companies in the research and development of clinical, animal and laboratory studies designed to promote pharmaceutical drugs and medical device products specializing in wound healing and burn care. Additional Services: •Development…
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…
Patent Infringement, Implants, Medical Devices, Surgical Devices, Surgical Implants, FDA
Expert has expertise in certain medical devices and surgical devices. He also has expertise in certain medical implants and surgical implants.
Computer Aided Design, Finite Element Method, Mechanical Engineering, Biomechanics
Expert is the Director of the Medical Engineering Research Group at Employer and a Senior Lecturer in Mechanical Engineering. Since completing her PhD in 2001, she has been applying mechanical engineering solutions to medical problems, mainly in orthopaedics. Expert's research…
Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals
Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and…
Life Science, Biotech, Pharmaceuticals: Research and Development, Smart Manufacturing/ Supply Chain, and Market Launch/ Commercialization
Expert has over 20 years of experience in strategic innovation, system building, and delivering value solutions for global markets. His focus is on building infrastructure synergies between science, technology, and finance. As a Strategic Advisor, he has experience with: •…