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Diagnostics

Customized Diagnostic Solutions

MRIGlobal Capabilities ChartNODROP-01

MRIGlobal’s diagnostic services span across all stages of clinical diagnostic product development process, from assay, method and platform development, through clinical validation, including FDA 510(k), Pre-Market Notification (PMN), and CE Mark Submissions. These services provide a turn-key, outsourcing solution for commercial companies and government  agencies to  accelerate product development, moving product into the market and capabilities into the field.

  • Assay Optimization and Development

Utilizing sophisticated techniques and approaches, MRIGlobal Dx assists with the optimization and development of a wide variety of molecular diagnostic assays for real-time PCR, sample-to-answer, and sequencing including next-generation sequencing.

  • Product Development

Moving your clinical product through development to commercialization, efficiently and effectively.

  • Design Control

Working with partners to 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 will generate critical stability data to be included in your product insert.

  • Sample Management

Initial receipt, handling, and disposition of clinical samples including long-term storage while maintaining chain-of-custody with electronic tracking systems.

  • Biorepositories

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

Contact

Rich Masino, Senior Sales Director
Commercial Contact
858-342-1574

Joe Bogan, GHSD Director
Government Contact
240-888-7552

Request Information

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…

read more

Upcoming Events

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    ASM CVS (American Society of Microbiology Clinical Virology Symposium)

    Palm Beach County Convention Center in West Palm Beach, Florida

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 9001:2008 (transitioning to 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.