Diagnostics
Customized Diagnostic Solutions
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…
Upcoming Events
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.