RDI is your full-service, integrated IVD CRO
With clinical trial services to support the full life cycle of your product, we are dedicated to IVD and have the extensive domain expertise necessary to support you through all product validation pathways.
Backed by a technologically forward approach and extensive experience, we accelerate your IVD research.
Regulatory Consulting
By combining regulatory and clinical services, we save you time and increase the likelihood of your product’s approval. From the initial stages of defining the most effective regulatory pathway to the details of your study design and preparing submission documents, our team is dedicated to guiding you every step of the way.
By reaching out to the FDA with a proposal plan early and using our site network to guide feasibility, we help you avoid surprises and minimize delays.
1
Develop
Based on your product’s unique requirements and specifications, we use our experience in IVD development to determine an ideal regulatory strategy.
2
Submit
We manage your 510(k) pre-submission or PMA submission package to the FDA.
3
Design
RDI designs the IVD research studies necessary for analytical verification and validation, as well as clinical validation.
4
Conduct
Our CRO stands by to support your IVD studies with laboratory infrastructure, clinical sites, and clinical research services.
5
File
We file your final submission material to the FDA and ensure successful completion of your regulatory process.
