In Vitro Diagnostics Consulting and Development Services


ResearchDx can provide complete turnkey IVD Development from concept to approval and are equally adept at working with established companies to seamlessly integrate only the components needed for your current framework. Please contact us for your specific development requirements.


Our IVD Development Services include:


Our laboratory facilities are capable of performing both clinical and analytical studies for 510(k) and PMA applications.

ResearchDx has extensive experience as both a primary site performing all analytical and clinical studies, and as a secondary testing site performing analytical (reproducibility) studies.


  • Pre-IDE Development, Regulatory Strategy, and Predicate Determination (510(k) only)
  • Clinical and Non-clinical Project Requirements
  • Program Design, Implementation and Oversight
  • FDA Interactions, Submission Assembly and Follow-up


  • Project Management
  • Project Monitoring (Initiation, Interim and Closeout)
  • Site Identification, Qualification and Management
  • IRB / Ethics Committee: Central and Local Submissions and Management
  • Sample Procurement, Collection, Processing, Distribution and Accountability
  • Study and Site Documentation Development and Management
  • IUO Reagent / Equipment Management, Distribution, Accountability and Return


  • Statistical Analysis Plans
  • Statistical Project Management and Support
  • Statistical Analysis, Reports and Tables
  • Data Management Plans
  • Data Project Management and Support
  • Data Collection Tools (Worksheets, CRF, eCRF)
  • Database Development, Validation and Management

Kit Manufacturing

ResearchDx has extensive in-house and outsourced kit manufacturing expertise. Regardless of whether you need something as simple as a IUO assay for reproducibility studies, or something as complicated as the selection of a manufacturer for global distribution, ResearchDx can provide an array of options.