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MRIGlobal’s Commercial Diagnostics Capabilities

In Vitro Diagnostics

At MRIGlobal, we provide scientific and subject matter expertise to expand and accelerate the delivery of high quality clinical diagnostic products. Anyone seeking out diagnostic and detection device development can trust our experience in commercial diagnostics.

We offer commercial clients services including assay design, assay development, analytical verification, and clinical validation through regulatory submission. We provide extensive research and product development expertise; facilities, analytical services, clinical trial site, and clinical trial services and support; and regulatory guidance to support FDA, EUA and 510(k) submission filings.


Flexible enough to meet your needs

There is no limit to what we can accomplish at MRIGlobal, so no matter the size of your company we can help with diagnostic and detection devices around the world. Sometimes we partner with a company from initial conceptualization to creating multiple prototypes, testing and optimizing them, all the way through to the regulatory submissions. 

Other times we partner with large companies who have a great deal of in-house capabilities, but need multiple sites for validation studies. MRIGlobal stands apart from the crowd of CROs with our available Biosafety Level 3 laboratories.

Whatever your commercial diagnostics needs are, we are here to fill in the gaps.  


Getting started with MRIGlobal

Contact MRIGlobal and get started with developing your diagnostic platform, analytical verification testing, clinical validation, and regulatory support.

As a not-for-profit contract research organization, we have proven ourselves as an objective partner driven to make our clients’ products more successful. We specialize in defense, human health, pharmaceutical sciences, clinical diagnostics, energy and environment, agriculture, and global health.

To learn more about the work we’ve done or how we can help you, contact us today. If you are part of an agency, business, or academic institution seeking assistance with a project, use our Project Quote Tool to get started.

Project Quote Tool


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