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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: 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: 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: 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: 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: 729945 California, USA

Expert in Competitive Intelligence from Primary Sources in Pharmaceuticals, Diagnostics, and Medical Devices.

•Business research and development professional with a successful record targeting and developing Fortune 500 clients. •Founded pharmaceutical and information technology business intelligence firm and served as Business Development & Research Director for 15 years. •Expertise assessing the unique challenges facing…

Expert ID: 729362 Massachusetts, USA

Expert in Clinical Diagnostics, Immunoassay Product Development, Clinical Toxicology

ExpertSiek has two major areas of Expertise: 1) He has been involved in all aspects of In Vitro Diagnostic Immunoasasy and Clinical Chemistry Product Development Including Laboratory Research and Development, Transfer to Manufacturing, Documentation to meet QSR including Design History,…

Expert ID: 729349 Michigan, USA

Expert in Research and Development, Smart Manufacturing/ Supply Chain, and Market Launch/ Commercialization

Technological / Scientific Infrastructures Speed to Markets • Advising and Strategically Coordinating with the Following Agencies:  World Health Organization COVID-19 Accelerator Cure Project  Linking Collaboration Platforms for Best in Class Teams around the world  The Directorate for…

Expert ID: 728850 Washington, USA

Expert in Design & Development of Molecular IVD Assays, including Design Control, Risk Analysis, Submissions

Expert has 15 years’ work experience in the development of nucleic acid -based in vitro diagnostic (IVD) devices. He has both theoretical knowledge and hands-on experience, spanning the entire IVD pathway, which includes biomarker discovery, preclinical & clinical assay validation,…

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