• RCRI is now a part of Covance

    More Medical Device and Diagnostic Solutions for the life cycle of your product. Learn more.

RCRI is the leading clinical research organization, medical device consulting firm and strategic regulatory expert.

Getting a medical device to market and gaining proven, value-based market adoption is more difficult today than ever. Regulatory bodies are demanding more safety and efficacy data for approvals. Payers want compelling economic evidence. Healthcare professionals need confidence that the product will solve their problem.

Complex challenges like this require strategic thinking from a partner with deep expertise. RCRI combines years of regulatory, clinical and marketplace experience for a proven integrated approach that gets your product to market quickly and successfully.

Technology

We work across medical specialties from cardiology to wound healing.

Our Integrated Approach Drives Market Success

  • Discovery

    • Regulatory Affairs & Strategy Development
    • Health Economics & Reimbursement
  • Evidence Formation

    • Clinical Study Design & Operations
    • Biostatistics & Information Management
  • Post-market Compliance

    • Post-market Evidence Development
    • Quality Systems Support
  • Development

    • Clinical Strategy
    • FDA/Regulatory Body Strategy Negotiation
  • Regulatory Submission

    • Regulatory Body Negotiation & Response

Supporting you through all phases of product development

From simple modifications of market-released products to novel combination products, our deep experience and proven integrated approach removes obstacles to expedite approvals with major regulatory agencies and notified bodies around the globe.

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