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Expert ID: 733788 North Carolina, USA

Expert in IVD Assays and Diagnostic Tests Development

Expert's areas of expertise include the following: IVD (in vitro diagnostics) clinical laboratory regulation molecular diagnostics blood assay diagnostic instrumentation assay development CLIA-88 (Clinical Laboratory Improvement Amendments of 1988) clinical laboratory regulation quantitative risk analysis (risk assessment) laboratory management GLP…

Expert ID: 731601 Connecticut, USA

Expert in Clinical Laboratory Science, Lab Directing, Lab Diagnostics, Medical Technology, Hosp, Testing

Expert is a clinical laboratory scientist with 30 years of experience in the industry covering laboratories in the hospital, national reference, and large physician office settings. He is the founder of a consulting company which began in 2009. The company's…

Expert ID: 731691 Georgia, USA

Expert in In Vitro Diagnostics Industry Including Clinical Laboratory, Immunohematology & Donor Screening

Expert's 40+ year career has spanned a variety of business disciplines and functions including information management, supply chain management, customer service, new product development, sales, and new business start-up. He began his career at Eastman Kodak Company as a Systems…

Expert ID: 731486 Colorado, USA

Expert in CLIA/CAP/NYS Laboratory Testing; Tissue/Cornea/Live Cell Donor Suitability

Expert is one of the world's leading experts on eye and tissue banking, as well as being a pioneer in the field of personalized medicine. His company provides CLIA-qualified laboratory directors to labs throughout the United States, as well as…

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: 730118 Washington, USA

Expert in Hospital Tests and Kits, Clinical Chemistry, Coagulation, Serum Controls, Manufacturing Processes

Expert received his PhD in Biochemistry (Enzyme kinetics on NAD kinase in 1981), where he proposed a mechanism, Rapid Equilibrium Random with two dead end complexes for the enzyme, using enzyme inhibition studies. He was able to apply this knowledge…

Expert ID: 729840 Florida, USA

Expert in Internal Medicine, Hospital Medicine, Utilization Review, CMS Compliance, Faculty, Telemedicine

Expert is board-certified in Internal Medicine by the American Board of Internal Medicine. He has been practicing as a hospitalist (inpatient internal medicine) since finishing his residency training in 2007. He has worked in major, tertiary-care, referral hospitals and in…

Expert ID: 728719 Massachusetts, USA

Expert in Drug Development (Small Molecules, Peptides, Biologics, Parenteral Nanoparticles); Drug Delivery

ExpertJung is an expert in analytical instrumentation and analytical methods development and validation, especially for drug regulatory filings with the FDA and EMEA according to all FDA and ICH guidelines. He established a state-of-art core instrument department at Altus Pharmaceuticals…

Expert ID: 727627 New Jersey, USA

Expert in Strategy and Sales Analysis for In Vitro Diagnostics and Biopharmaceuticals

Expert has multiple experiences in evaluating and proposing strategy for brands or individual products. This list includes several existing diagnostic products where lifecycle planning needs require judicious selection of new and novel add-ons to an existing line. It also includes…

Expert ID: 724131 Illinois, USA

Expert in Commercialization of Scientific Devices, Inventions, Scientific Management Consulting, etc.

Expert has used his experience and knowledge of biochemistry and biophysical measurement to create tools for measurement of clinically significant targets for the biomedical industry. He has developed Drugs of Abuse and many other assays, supported the development of complex…

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