In Vitro Diagnostics | Research, Development, Test, and Evaluation
Radiation exposure poses a real threat to US and global populations.
Following a radiation incident, diagnostic tests for absorbed doses are critical for informing the use of medical countermeasures and saving lives. MRIGlobal’s radiological exposure diagnostic services span all stages of the in vitro diagnostic product development process through clinical validation, including FDA 510(k), Pre-Market Notification (PMN), and CE Mark Submissions.
We offer services and develop protocols related to diagnosis of radiation exposure:
Project management and integration oversight, coordination of collaborators, and facilitation of FDA interactions
Nathan Henderson and Carolyn Culp operate a Bio-mek Fx liquid handling system to prepare clinical samples for radiological exposure testing.
MRIGlobal scientists conduct testing and evaluation to support radiological exposure diagnostic technology development. We work hard to streamline FDA clearance of products.
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