In Vitro Diagnostics Solutions
Support for confident clinical, biodefense, and public health decision-making
Expertise for IVD Development
MRIGlobal provides expertise spanning assay design, prototyping, analytical verification, reproducibility and performance testing, clinical validation, and regulatory strategy to develop in vitro diagnostic (IVD) solutions. Our team supports development across CLIA complexities—from high-complexity tests to moderate- and waived-complexity assays, including home-use diagnostics. With testing that can be performed in two geographically distinct locations, we enable robust reproducibility studies that strengthen confidence in assay performance across sites.
Areas of Expertise
Our IVD Services
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Assay & Method Development
Develop and validate IVDs to support regulatory clearance -
Bioinformatics & Data Science
Transform complex biological data into actionable insights that facilitate IVD development -
Clinical Study Strategy & Execution
Generate data to validate IVD performance through clinical study design and execution -
Prototype Development
Develop and refine IVDs for scalable, real-world applications -
Regulatory Strategy & Submission
Strategy, documentation, and submissions for clearance and market access -
Verification & Validation
Analytical and clinical testing to generate regulatory-ready data
"MRIGlobal is on our list of qualified and preferred vendors for IVD companies needing analytical testing."
Latest from the blog
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The Threat of Antimicrobial Resistance
There are potentially billions of different types of bacteria, and they’re found almost everywhere. Some are friends while others are foes. Studies show that kitchen sponges contain 45 billion bacteria per square centimeter. Another study suggests that your desktop has 400 times more bacteria than your toilet seat. And did you know that the average […]
Assay & Method Development Biosurveillance & Threat Detection Detection & Diagnostics -
Battling Antimicrobial Resistance
When an antibiotic treatment regimen is not successfully completed by a patient, the surviving bacteria have encountered the evolutionary pressure of the antibiotics that killed off a majority of their weaker population. These surviving, stronger bacteria are able to persist and continue growing inside the patient, eventually becoming strong enough to again cause symptoms. Because […]
Assay & Method Development Biosurveillance & Threat Detection Detection & Diagnostics -
Should I Be Concerned About Tuberculosis?
In August 2025, new tuberculosis cases have been detected in Northern California and Washington, prompting concern for those infected and about its possible further spread in those communities. But should you be concerned? Previously in January 2025, an ongoing tuberculosis (TB) outbreak in Kansas became one of the largest outbreaks in U.S. history, dating back […]
Biological Threats Product Development Verification & Validation
