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Physics, Mechanical Engineering, Medical Device Product Development, Blood Collection for Diagnostics & Therapeutics, Patent Litigation Expert Witness
Expert is Founder and Principal Consultant at a consulting firm founded in 2015, focused on industrial mechanical engineering and research and product development, in medical devices, diagnostics, optical, imaging, and laser devices, point-of-care blood sample testing, and on expert witness…
Clinical Laboratory Science, Lab Directing, Lab Diagnostics, Medical Technology, Hospitals, 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…
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…
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…
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…
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…
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…
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…
Drug Development (Small Molecules, Peptides, Biologics, Parenteral Nanoparticles); Drug Delivery
Expert 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…
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…