About Medical Device Consultants - MDCI
MDCI is a full-service contract research organization (CRO) and consulting firm that helps emerging and established firms commercialize novel and innovative medical devices, in vitro diagnostics and combination products.
Since we began operations in 1980, clients have turned to us for strategic consulting and tactical solutions to understand and overcome regulatory, compliance, and clinical trial challenges at all stages of the medical product lifecycle.
In the area of IVDs, we have significant experience with traditional IVDs, as well as more recent molecular diagnostics, laboratory developed tests (LDTs) and In Vitro Diagnostic Multivariate Index Assays (IVDMIAs).
With MDCI you have access to a team of in-house consultants and clinical project managers who have extensive experience navigating global regulatory and clinical trial requirements to meet the requirements of the U.S. Food and Drug Administration (FDA), Europe (IVDD, MDD, AIMDD), and Health Canada.
Contact us today to learn about our medical device consulting services.
Expert guidance to support your journey from medical device concept to launch
Contact Us
Reach our Massachusetts office at 1-508-643-0434, Monday through Friday, 9:00 a.m. to 5:00 p.m. Eastern. Or fill out our contact form and a consultant will contact you directly.