Diagnostics Development Services 2018-08-23T14:59:00+00:00

Project Description

Diagnostics Development Services

Health Decisions offers comprehensive clinical development services for diagnostics in all therapeutic areas. Offerings for diagnostics developers include management and execution of PMA, 510(k) and combined 510(k)/CLIA waiver studies as well as strategic advice and regulatory services. Health Decisions has extensive experience in large subject-based studies to demonstrate clinical validity and utility and has conducted studies of all types of diagnostics, including IVDs, LDTs and point-of-care diagnostics. 

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