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Customized Diagnostic Services

MRIGlobal Capabilities ChartNODROP-01

MRIGlobal in vitro diagnostic services span all stages of the clinical diagnostics product development process, from assay, method and platform development, through clinical validation, including FDA 510(k), Pre-Market Notification (PMN), and CE Mark Submissions. If your product is headed for the FDA, IVD services from MRIGlobal provide a turnkey outsourcing solution that simplifies the process of getting your product to market your capabilities into the field.

Does your product involve immunodiagnostics, molecular diagnostic assays, or even companion animal diagnostics? MRIGlobal’s clinical diagnostics expertise includes these areas and more.

  • Assay Optimization and Development

MRIGlobal Dx uses sophisticated techniques and approaches, to assist with the optimization and development of molecular diagnostic assays for real-time PCR, sample-to-answer, and sequencing including next generation sequencing (NGS).

  • Product Development

Our IVD services move your clinical product through development to commercialization, efficiently and effectively.

  • Design Control

Our team can establish, validate, verify, and control the development process of medical devices (21 CFR 820.30). We can work with your Design History File or provide our own. 

  • Stability Studies

MRIGlobal gathers the critical stability data needed for your product insert.

  • Sample Management

We can handle the initial receipt, handling, long-term storage, chain-of-custody using electronic tracking, and disposition of clinical diagnostics samples.

  • Biorepositories

MRIGlobal Dx provides the equipment, personnel, and related resources to support large repository collections including automated sample handling and enhanced storage inventory management.


Rich Masino, Senior Sales Director
Commercial Contact

Joe Bogan, GHSD Director
Government Contact

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Featured Work

Molecular Biodosimetry Development program for BARDA

MRIGlobal, with key partners Thermo Fisher Scientific and Arizona State University (ASU), will lead a molecular biodosimetry development program for the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness Response within the U.S. Department of Health and Human Services. The contract, worth more than $21.3 million over the first four…

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Customized Solutions

  • R&D, IVD, LDT, CLIA-WAIVABLE, and RUO products
  • FDA 510(k), PMN, and CE Mark Submissions
  • Limit of Detection
  • Inclusivity (Reactivity)
  • Exclusivity (Cross-Reactivity)
  • Interfering Substances
  • Reproducibility
  • Sensitivity and Specificity
  • Limit of Detection
  • Inclusivity (Reactivity)
  • Exclusivity (Cross-Reactivity)
  • Interfering Substances
  • Reproducibility
  • Sensitivity and Specificity
  • Limit of Detection
  • Inclusivity (Reactivity)
  • Exclusivity (Cross-Reactivity)
  • Interfering Substances
  • Reproducibility
  • Sensitivity and Specificity
  • Accelerated and Real Time (-80C, -20C, 4C, RT)
  • CLIA (CAP accredited) Reference Laboratory Services & Support for Diagnostics Comparative Studies

Dedicated, high-quality resources for rapid turnaround

  • CAP-accredited CLIA Reference Laboratory
  • BSL-3 and BSL-3+ Laboratories for Handling Emerging Infectious Diseases & Select Agents
  • Highly Secure Facilities
  • 60+ Scientists, Engineers, Bioinformatics Specialists and Program Managers available to support and develop your product

Our Quality

Our Quality Management System (QMS) includes a Quality Assurance program to ensure all clinical diagnostic research, product development and laboratory services are documented, defensible, and of known and acceptable quality.

The QA and Regulatory staff have certificates in and are in compliance with:

  • ISO 9001:2015
  • ISO/IEV 17025
  • CLIA (CAP-accredited) Reference Laboratory
  • cGLP
  • cGMP
  • Quality System Regulation (QSR)
  • Successful audit history with FDA, CAP, ISO, DoD, CDC, EPA, DHA, USDA

Our Facilities

MRIGlobal Clinical Diagnostic Services are headquartered from its Palm Bay, Florida location with support from MRIGlobal’s Gaithersburg, Maryland regional facility.

  • Clinical Diagnostic Headquarter in Palm Bay Florida have Clinical and general research and development (R&D) laboratories (>70,000 ft2) , College of American Pathologist (CAP) accredited CLIA laboratories (1,000 ft2) and BSL-3 laboratories (>3,000 ft2)
  • R&D and BSL-3 Laboratories are utilized for biotechnology, molecular biology, immunology, microbiology, and virology, as well as engineering and bioinformatics. The CAP Accredited CLIA laboratories serve as a clinical testing site.
  • Maintain current registration, permits and unique access to work with infectious disease agents from the Department of Health and Human Services, United States Department of Agriculture, Universities, hospitals and the Centers for Disease Control and Prevention, allowing MRIGlobal to be mission-capable for project work immediately following contract award.
  • Extensive culture collection of well-characterized pathogens and has access to additional strains and clinical samples of interest through an existing network of laboratories worldwide.

Your Trusted Partner for Contract Research and Product Development Since 1944

From research through product development and FDA/CE-IVD submission, MRIGlobal provides the right people, capabilities, and facilities for the development of clinical diagnostic products to accelerate timelines, and deliver high-quality, customized solutions.