Verification & Validation
Analytical and clinical testing to generate regulatory-ready data
Accelerating Diagnostics from Concept to Market
MRIGlobal’s extensive expertise spans the entire product development lifecycle from early-stage assay development through early-stage assay feasibility. Within our Diagnostics Center of Excellence laboratories, our team supports all regulatory required verification and validation testing for a wide variety of indications, including generation of the data needed for regulatory clearance/approval. These capabilities help reduce development risk and can accelerate regulatory pathways, supporting our partners in confidently bringing high-quality IVD products to market.
Characterizing Diagnostic Performance
Emerging and Chronic Disease IVDs
Support accurate detection, improved patient outcomes, and enhanced public health preparedness.
Analytical Studies Including Environmental and Flex Testing
Evaluate diagnostic performance and product robustness, and validate reliability across real-world operating conditions.
Clinical Comparator and Clinical Study Testing
Provide testing expertise to evaluate diagnostic performance, generate high-quality clinical evidence, and support regulatory submissions.
Latest from the blog
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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 -
MRIGlobal Tests First Non-EUA Flu and COVID-19 Diagnostic
CDC estimates that since 2010, except for the 2020-2021 flu season, flu has resulted in between 9 million and 41 million illnesses annually in the United States. Its symptoms can include fever, chills, cough, sore throat, and runny nose. And since it was first reported in March 2020, COVID-19 has totaled more than 104 million […]
Assay & Method Development Biological Threats Product Development -
MRIGlobal Helps Accelerate Approval of Hep C Diagnostic
The World Health Organization (WHO) estimates that 50 million people globally have a chronic hepatitis C virus (HCV) infection. HCV is a bloodborne virus that affects the liver and can lead to lifelong illness including liver cirrhosis and cancer, which can be life-threatening. It is also estimated that in 2022, approximately 242,000 people died due […]
Assay & Method Development Regulatory Strategy & Submissions Verification & Validation
