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Expert ID: 733713 Texas, USA

Expert in Sterility Assurance Expert in terminal sterilization (Ethylene Oxide, Moist Heat, Radiation, Dry Heat) and Aseptic Processing to Medical Device and Pharmaceutical companies.

. Expert is President and Principal Consultant for his consulting company - a consulting LLC. Prior to going into consulting, he was Director of Corporate Quality Technology/ Sterilization Science, for Alcon a Novartis company where he was responsible for sterilization…

Expert ID: 734924 California, USA

Expert in Medical Device Engineering

He worked on hazard analysis of medical devices such as biochemical sensors. He worked on packaging processes of medical devices such as implantable catheters. He worked on packaging materials of medical devices such as plastic packaging. He worked on manufacturing…

Expert ID: 730258 California, USA

Expert in 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…

Expert ID: 729236 California, USA

Expert in 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…

Expert ID: 726401 New York, USA

Expert in Hydrogel Science and Technology for Drug Delivery, Medical Devices and Consumer Products

Expert’s major contributions are in microbial control of wide range of medical devices and pharmaceuticals. He has a background in chemical engineering and polymer science. He has decades of experience from numerous companies- large device and pharmaceutical companies to startups…

Expert ID: 725176 California, USA

Expert in Nanobiotechnology, Drug Delivery Platforms, Medical Devices, Targeted Therapeutics, Diagnostics

Expert has extensive experience establishing R&D operations in early stage biotechnology companies. He applied his knowledge in nano(bio)technology to develop innovative solutions to drug delivery and drug targeting challenges. His efforts to enhance the use of biomaterials in a variety…

Expert ID: 713381 Minnesota, USA

Expert in Medical Technology

A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination products. Expert is proficient in total quality systems requirements…

Expert ID: 727301 Washington, USA

Expert in 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…

Expert ID: 723272 New Jersey, USA

Expert in Parasitology, Immunology, Microbiology, Bioterror Agents, Grant Writing, Med Writing, Expert Witness

Expert has extensive experience in the preparation and submission of 510(k) documents to the FDA for approval of Class II medical devices. His first work in 510(k) preparation and submission was in 1987 for acceptance of a rapid immunoassay for…

Expert ID: 107647 Minnesota, USA

Expert in Technical Problem-Solving for Materials and Processes

Expert has extensive experience in both gas and liquid chromatography. He has studied theoretical mechanisms of separation and published application techniques in environmental and biological areas. Skilled in the use of data acquisition and data handling systems, Expert is particularly…

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