MRIGlobal Solutions for IVD and Molecular Diagnostic Developers
MRIGlobal provides contract services and solutions for Diagnostic products. Our team of scientists and engineers can provide an integrated approach to help you achieve goals toward FDA regulatory clearance and product launch.
We Feature:
- Assay development for menu expansion on your technology platform
- Validation and clinical testing
- Sample access and reference material
- Platform engineering and integration: software, hardware and chemistry/biology
- Development of Companion Diagnostics
- Partnership for entire development process or at any stage of the development process
- Not-for-profit with stable history – more than 68 years in business
Our Culture is Dedicated to Quality and Customer Service.
MRIGlobal’s Infrastructure Includes:
- QSR/Design Control, ISO 9001, ISO 17025, ISO 34
- CAP- accredited CLIA laboratory
- BSL-3 laboratory for emerging infectious disease work
- Strict quality control includes cGMP, GLP
- Expert team
- Molecular biologists
- Microbiologists
- Engineers
- Analytical chemists
- Program Managers
- Regular service provider to the US Government, including DOD and the NCI
Network Member of Clinical Assay Development Program