Medical Device Regulatory Consulting Services

Bringing subject matter expertise to regulatory compliance

  • Clinical Evaluation

    • Clinical Evaluation Reports & Plans
    • Literature reviews & data analysis
    • Notified Body engagement support
    • Clinical Evaluation Reviews

    Market-leading Clinical Evaluation and CER-writing services delivered by MDR-trained medical professionals with extensive data analysis and medical writing expertise.

    Learn more about our Clinical Evaluation service

  • Medical Writing

    • Clinically-active medical writers
    • Subject Matter Experts
    • MDR compliant documents & protocols
    • Data analysis & literature reviews

    Regulatory Medical Writing services designed for EU MDR compliance and delivered through the expertise of real medical professionals.

    Learn more about our Medical Writing service

  • Clinical Evidence Generation

    • PMCF Studies & Surveys
    • PMCF Plans & technical documents
    • GDPR-compliant data collection
    • Clinical Investigators & Sites

    Powerful PMCF systems designed by medical experts utilising pre-approved clinical investigators to generate high-quality clinical evidence for your medical device.

    Learn more about our Clinical Evidence Generation service

  • 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 service

Clinical Investigators & Sites

Our database of pre-approved clinical sites and investigators means we can match your devices with motivated investigators interested in conducting PMCF studies.

  • Extensive database of clinical investigators

  • Pre-approved for PMCF studies

  • Rapid on-boarding & study initiation

  • Access to a broad range of clinical sites

Visit Clinical Investigators

Start today

  • Do you need a new regulatory partner?
  • Are you starting from scratch?
  • Would you like a quote for our services?

Start your free and confidential consultation by contacting us today.

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