Medical Device & Diagnostics Resources

Case studies and resources for medical devices and diagnostics

We know the special challenges of each therapeutic area. We have hands-on experience across key regulatory jurisdictions and patient populations worldwide, and we understand the nuances of such diverse device categories as cardiovascular, orthopedic and spine, combination products, and general surgery.


Heart Valve Replacement: A Full-Team Approach for Operational Success

The Role of Clinical Endpoint Committees in Medical Device Trials

Medical Device Regulation: Finding Your Path to Success

Applying Sound Research Practices in Development of Medical Devices


Premier Research has conducted 187 medical device studies in the past five years alone.

Medical Device_2016_07


Case studies

White Papers

  • Medical Device Development: Pathways to Approval in the U.S. and the EU
  • Clinical Endpoint Committees: Ensuring the Quality, Validity, and Integrity of Clinical Trial Results
  • Applying Sound Research Practices in the Development of Medical Devices
  • Useful information

    Sponsor Responsibilities in Medical Device Clinical Trials

    Medical Device Market Approval

    Medical Device Market Approval

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