Prototype Development
Develop and refine IVD prototypes for scalable, real-world applications
Accelerating Innovations to Market
Our team of scientists and engineers designs, develops, and refines IVD prototypes that support lab-based, point-of-care, and point-of-need applications. Through translation of early-stage concepts into functional, scalable prototypes, our team evaluates performance, manufacturability, regulatory readiness, and operational effectiveness. MRIGlobal’s expertise can help accelerate product innovation, reduce technical risk, and efficiently advance IVD solutions from concept to commercialization.
Advancing Diagnostic Innovation to Assist Market Access
Human Factors Engineering
Apply human factors engineering best practices to enhance user experience and performance.
Point-of-Care Diagnostics
Support development through verification and validation, and regulatory expertise for use in CLIA waived and PoC/PoN settings.
Home Use Diagnostics
Engineer to deliver reliable, accurate performance for tests performed at home or by lay users.
Regulatory Alignment
Align development with FDA and global regulatory requirements.
Consumable/Device Engineering and Assay Integration
Combine molecular or immunoassay chemistry with consumables and hardware systems to create complete diagnostic platforms.
Rapid Proof-of-Concept Development
Translate diagnostic ideas into working prototypes for early feasibility and testing.
