Medical Device Regulation Resources

Gain understanding of MDR & IVDR regulation through our library of exclusive resources

Sandra Gopinath, Chief Regulatory Officer

  1. An EU flag

    EU MDR Compliance Guide

    Our free EU MDR Compliance Guide covers many topics relating to Medical Device Regulation. It's a great starting point to help direct your regulatory strategy.

    • Clinical Evaluation
    • PMS & PMCF
    • Risk Management
    • Quality Management Systems
    • Plus 20 other topics
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  2. AI-powered MDR and MDCG chatbot by Mantra Systems

    EnableChat

    If you find it difficult finding MDCG documents and MDR articles, try asking our AI-powered chatbot your regulatory questions and you'll get an answer back in seconds.

    • Search the MDR & MDCG Guidelines
    • Ask a question in any language
    • Get an answer in seconds
    • No sign-up, it's FREE
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  3. Someone using a regualtory guide

    White Papers & Guides

    Understand important areas of the medical device regulatory environment with our free White Papers and Guides.

    • MDReady Starter Guide
    • Mastering the MDR
    • PMS in the MDR
    • Software as Medical Device
    • More coming soon
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  4. A woman taking a regulatory training course

    Online Training Courses

    A range of professional online video training courses suitable for any existing level of regulatory knowledge.

    • Introductory to advanced topics
    • Step-by-step guidance from experts
    • Choose the right content for you
    • Stream videos online 24/7
    • Gain certainty & peace of mind
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  5. A laptop workstation with regulatory templates

    Document Templates

    Build your technical file through proven frameworks enhanced by detailed guidance from our specialists.

    • Choose the resources you need
    • Eliminate doubt in your systems
    • CERs, CEPs, Annex II & more
    • Step-by-step guidance from experts
    • Direct, immediate & future-proof
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  6. A woman reading & taking notes on a Medical Device Regulation article

    Articles & News

    Read our analysis and get guidance on regulatory requirements including developments in the industry.

    • PMCF strategies
    • Regulatory compliance guidance
    • Clinical Evaluation best practice
    • Future of the UK & EU MDR
    • Plus many more subjects
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  7. Using the PMCF Checker

    PMCF Checker

    See if your medical device requires a PMCF system for regulatory compliance.

    • Answer 10 quick questions
    • Clarity on your PMCF obligations
    • Takes just a few minutes
    • Free to use
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MDReady Starter Guide Begin your EU MDR compliance journey with a free step-by-step guide

Free download — MDReady Starter Guide Free Download