Medical Device Regulatory Resources

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

  • 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

MDR Training Academy

  • Risk Management

  • Quality Management

  • Post-Market Surveillance

  • Document Management

The Mantra Systems Academy is the complete MDR compliance support program. Integrating education, training, support, templates and full document management, it 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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