• Unmatched Expertise

    No other medical device consulting and clinical research organization has more expertise than RCRI. That’s because no other organization integrates clinical research, regulatory affairs and a consultative partnership approach to the development process. We help entrepreneurs transform their life-changing medical device concepts into successful, revenue-generating products for markets all over the globe.

  • Integrated Approach

    RCRI is where big picture thought leadership meets small detail clinical scrutiny. We integrate our regulatory consulting and reimbursement strategies with the depth of our clinical trial services. As a result, we bring your ideas from mind to market more effectively, cost efficiently and nimbly.

  • Global Experience

    More than 600 companies – from entrepreneurial start-ups to Fortune 100 market leaders – and countless investors, medical professionals and patients have benefited from our extensive clinical research organization services and medical device consulting experience.

  • Scientists First

    All RCRI strategic consultants are experienced scientists who know that asking “why?” is just as important as asking “how?” Our advisors come from a breadth of disciplines, and will design and execute strategies for robust evidence development to meet stakeholder demands.

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.


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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