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Expert ID: 108404 Indiana, USA

Expert in Medical Diagnostic Tests

MEDICAL DIAGNOSTIC TEST FORMULATING; ORGANIC SOLVENT; SEMISYNTHETIC POLYMER. Expert has spent 21 years engaged in adapting analytical techniques to the quantitative analysis of medically significant substances. This has involved combining pH buffers, enzymes, chromogens, and stabilizers to make a marketable…

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: 736123 Indiana, USA

Expert in Medical Device Quality Assurance and Regulatory Compliance

Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…

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: 731674 California, USA

Expert in Medical Device Product Management, Product Launch, Marketing, Sales and Sales Operations

Our advisor is currently the CEO of Expert Consulting Group, Inc., an independent consulting firm. The San Diego-based consultancy provides strategic advice to start-up medical device companies, including assistance with product management/development, clinical studies, and marketing and sales operations (e.g.,…

Expert ID: 731334 Illinois, USA

Expert in Medical Device Strategy, Up-stream Marketing and Commercialization

Expert has over 30 years marketing experience in the healthcare industry. During his career he has launched over 20 products in the USA and internationally. Products launched include electronic medical equipment, durable medical equipment, medical plastic consumables, and medical software.…

Expert ID: 730884 California, USA

Expert in Infectious Diseases, Clinical Microbiology, Medical Mycology and Infectious Disease Research

Expert trained in Infectious Diseases at the University of California, San Diego in 1982. Since then he has been a faculty member in Infectious Diseases at a major university. He is a Fellow of the Infectious Disease Society of America.…

Expert ID: 730707 New Jersey, USA

Expert in Clinical Diagnostics, Life Sciences and Medical Devices

Expert has over 30 years' experience in clinical diagnostics, life sciences, and medical devices. Expert is President of a health care consultancy. He has experience in the identification, acquisition, and commercialization of new businesses and products in the clinical diagnostics,…

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: 730233 Pennsylvania, USA

Expert in Cardiac Electrophysiology, Cardiology Drugs, Pacemakers, Defibrillators, Cardiac Medical Devices

Expert. Expert is a board certified cardiac electrophysiologist (cardiologist with expertise in the diagnosis and treatment of all cardiac rhythm disorders) with over 20 years experience as a clinical investigator, IRB Chair, and high volume implanter of cardiac rhythm devices.…

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