Medical Device Regulatory Resources

Our range of resources contain exclusive documents & guidance on all aspects of MDR compliance

Sandra Gopinath, Clinical Evidence Regulatory Specialist

  • EU MDR Compliance Guide

    • Post-Market Surveillance
    • Risk Management
    • Quality Management Systems
    • Clinical Evaluation
    • ... and 18 other topics

    Our unique EU MDR Compliance Guide covers 22 topics relating to the new Medical Device Regulation (EU) 2017/745. It's free to use and combined with our online resources it will help direct your regulatory strategy.

    Read our guide

  • Articles & News

    • PMCF strategies
    • EU MDR Compliance guidance
    • Clinical Evaluation best practice
    • Future of the MDR
    • ... and other subjects

    Read our analysis on medical device regulatory requirements inlcuding our observations on developments in the industry.

    Read our analysis

  • EU MDR Downloads

    • MDReady Starter Guide
    • Mastering the MDR White Paper
    • PMS in the MDR White Paper
    • CER Template & Gap Analyser
    • ... and more

    Our EU MDR Downloads include exclusive White Papers, Templates, Tools & Guides which will help you understand important areas of the medical device regulatory environment.

    Get our downloads

  • PMCF Checker

    • Answer 10 quick questions
    • Get clarity about your PMCF obligations
    • Takes just a few minutes

    Our PMCF Checker is a quick test to see if your medical device needs a PMCF system for regulatory compliance.

    PMCF Checker

  • Video Library

    • What is MDR Compliance?
    • MDR stratgey guidance
    • What is Post-Market Surveillance
    • ... and other videos

    An archive of our publicly available videos discussing the EU MDR and our services.

    Watch now

MDR Academy

  • Document Management
  • Risk Management
  • Quality Management
  • Post-Market Surveillance
  • Templates Library
  • CER Accelerator

Our MDR Academy integrates education, training, support, templates and full document management into a platform which will empower your team to implement critical components of your MDR strategy without the need for outsourcing.

Learn more about our MDR Training Academy

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Get our MDReady Starter Guide A complete starter guide to get ready for the EU MDR

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