ResearchDx can devise, manage, and coordinate all aspects in the development of a diagnostic product.
We are one of very few companies in the diagnostics market with the ability to contract the entire development process of a medical product, or any component thereof. We can design, develop, integrate, validate, and transfer to manufacturing all aspects of an assay system, including:
- Biomarker discovery
- Assay design, development, and implementation as a LDT or IDT.
- Data Analysis
- PRE-IDE submissions
- Reproducibilty site selection and coordination
- Clinical and analytical verification and validation
- 510k or PMA development (Abbreviate and Special 510(k) available)
- Coordination with the FDA, Submission Assembly, and Follow-up
- GMP manufacturing services
- Software Documentation