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Clinical Comparator Testing

The work performed in our clinical comparator laboratories supports EUA and 510(k) submission filings through FDA, accelerating product approvals and market access for our customers.

Through the COVID-19 pandemic, work in these laboratories assisted customers in moving diagnostic devices through regulatory approvals. Our expertise and instrumentation support the process at a world-class level.  


Our clinical comparator capabilities meet the ever-evolving needs of our customers by hosting the necessary specialized instrumentation. Work performed in our CAP/CLIA regulated laboratories includes testing to support the first FDA-cleared over-the-counter COVID-19 test 


As new disease outbreaks occur, such as the 2023 Mpox outbreak, clients call on MRIGlobal for help in supporting approvals for these diagnostics as well. This necessitates constantly bringing new instrumentation on board to meet these needs.  


Visit an overview of all of our capabilities between Clinical Comparator Testing and Validation & Verification

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MRIGlobal looks forward to contributing our expertise where it matters most.

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