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Diagnostics

Customized Diagnostic Solutions

MRIGlobal is your trusted partner for contract research and development. From early product design to FDA 510(k) or CE-IVD submission, we offer a broad and deep portfolio of laboratory services, facilities, and scientific expertise to support and accelerate the development of in vitro diagnostic products.

  • Extensive Nucleic Acid Sample Prep and Isolation Services
  • PCR Test, Evaluation, Validation Services (TEVS)
  • Product Development Services
  • Diagnostic Product Test and Evaluation Services
  • CLIA (CAP accredited) Reference Laboratory Services
  • Next Generation Sequencing
  • Assay Design, Verification, and Validation Services
  • Unique Access to Samples
  • Biomarker Development
  • EIA and Bead-based Assays
  • Bacterial and Viral Pathogens, including High Path Influenza and Select Agents
  • Preparation and Design of Package Inserts
  • Analytical Methods Development and Technology Transfer
  • Engineering, Software, and Systems Integration Services
  • BSL-3 Laboratories

Contact

Rich Masino
858-342-1574

Request Information

Featured Work

MRIGlobal Supports Global Health with BARDA Medical Countermeasures Development

MRIGlobal Supports Global Health with BARDA Medical Countermeasures Development

Under the 5-year, Indefinite Delivery/Indefinite Quantity contract with a potential value of ​up to $100 million, MRIGlobal will support BARDA's mission to develop medical countermeasures and supportive reagents and assays against chemical threat agents for regulatory acceptance in the U.S. “MRIGlobal has a rich history of providing innovative science and technology solutions to BARDA and we are honored to continue…

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Upcoming Events

  • Sun
    06
    May
    2018
    Wed
    09
    May
    2018

    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

MRIGlobal’s overall 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 MRIGlobal QMS is certified to meet the standards of ISO 9001:2008, currently transitioning to ISO 9001:2015. In addition, specific laboratories are CLIA (CAP-accredited) and ISO/IEC 17025 accredited.

MRIGlobal 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

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.