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.

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

Medical Device_2016_07

Webinars and Speaking Engagements

Operationalizing the New MDR

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

The Role of Clinical Endpoint Committees in Medical Device Trials

Applying Sound Research Practices in Development of Medical Devices

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
  • Six Things You Need to Know About Medical Devices and Cybersecurity
  • Useful information

    Sponsor Responsibilities in Medical Device Clinical Trials

    Medical Device Market Approval

    Medical Device Market Approval

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