FDA Consulting

MRIGlobal is your key partner in disease diagnostic research, medical device testing, and FDA filing for Emergency Use Authorization (EUA) and 510(k) testing.

Our team of experts acts as your FDA consultant from research and development to test and evaluation and beyond. We have the expertise, the diverse team, and the clinical resources to get you through the challenges of FDA clearance, enabling you to execute at a higher capacity. Clients find our leadership as their FDA consultant invaluable to their diagnostic development portfolios.


Assay Design & Development

As an experienced FDA consultant, our clinical assay development aligns with FDA best practices and follows a Quality Management System (QMS). We know the levels of testing required and will use our knowledge to assess your unique portfolio for the fastest high-quality route to FDA submission and approval.

Device Development

Our disease diagnostics research and development and diagnostic device development capabilities include turnkey, outsourcing solutions for commercial and government clients and accelerated product development through analytical verification and clinical validation phases.

Studies & Testing

We will help build efficacy within your portfolio through analytical verification studies, clinical validation studies, independent platform evaluation, flex studies and usability testing, clinical reference testing, and more.

Device Trial Capabilities

We have the world-class laboratories and facilities, staff, clinical resources, and on-site capabilities you need to effectively test devices and products in a properly controlled environment under scientific supervision. Through this process, we will also ensure that all products and results are effectively preserved and meticulously reported to forge the strongest path to FDA clearance.

Regulatory Submissions

As your FDA consultant, we help prepare your portfolio for EUA, 510(k), and IVD-R submission. We know where to find the most appropriate predicates that will make and support your substantial equivalency claims.

Biosafety Training & Lab Development

Our team works in labs that are designated as BSL-1, BSL-2, BSL-2+, ABSL-2, BSL-3, BSL-3+, and ABSL-3+, with each requiring its own protocols and engineering controls. Our biosafety experts can also train your team in your labs, preparing them to conduct research safely.

Frequently Asked Questions

Our Staff

The diversity of expertise among MRIGlobal scientists means we can connect the dots in ways other CROs can’t.

As a team, we combine our varied backgrounds in therapeutics, biology, chemistry, pharmaceutical sciences, drug formulation, and other relevant components. Our core in biosurveillance is the pillar of our process, giving us a much broader understanding when working with infectious disease assays and guiding devices successfully through FDA clearance.


Work with us

MRIGlobal looks forward to contributing our expertise where it matters most.