Diagnostics
Customized Diagnostic Services
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.
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…
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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
Our Quality
Our Facilities
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.