Validation & Verification
Our laboratories in the Diagnostics Center of Excellence provide clients support for validation and verification studies throughout the lifecycle of their product development.
From initial assay design metrics to analytical validation, our teams systematically execute critical early-stage studies under regulatory standards, such as ISO 9001, ISO 17025, and GLP/GCP. These efforts are leveraged into the next branch of feasibility and clinical validation studies designed to provide feedback into potential testing strategies and risk mitigating efforts leading to a regulatory submission.
FDA clearance as well as CE-IVD labeling in the European Union.
Our clinical testing and diagnostics expertise supports evaluation of emerging diagnostic technologies for our clients with expertise in the record retention and support for ongoing clinical submissions. This includes the validation of a rapid, accessible, and portable SARS-CoV-2 genotyping panel.
Our support continues into the post-market deployment, where diagnostic devices meet real-time, emerging disease state trends. As prevalent circulating strains of pathogens are subject to variability, we are poised to identify targets and conditions that have the potential to negatively impact assay performance.
Utilizing diverse environmental chamber simulators, MRIGlobal conducts flex testing at a range of mild to extreme temperature and humidity conditions. Our environmental chamber boxes allow us to study long-term exposures of kit components to extreme environmental conditions. Alternatively, our walk-in chamber, capable of housing multiple test instruments, enables evaluation of the entire testing workflow under programmable environmental conditions. We even developed a solution to perform testing at altitude. These tailored solutions enable customized operating conditions to fit the specific needs of our clients.
Visit an overview of all of our capabilities between Clinical Comparator Testing and Validation & Verification