Project Description

Diagnostics Development Services

Health Decisions offers comprehensive clinical development services for diagnostics in all therapeutic areas, including IVDs, LDTs and point-of-care diagnostics, and has extensive experience in large subject-based studies to demonstrate clinical validity and utility. 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.

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