Medical Device Regulatory Services

Bringing subject matter expertise to regulatory compliance

  • Clinical Evidence Generation

    • PMCF studies & surveys
    • GDPR-compliant data collection
    • PMCF Plans & technical documents
    • 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 Clinical Evidence Generation

  • 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 Clinical Evaluation

  • 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 Medical Writing

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

MDR Training Academy

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.

Get started with our Academy

  • Risk Management

  • Quality Management *

  • Post-Market Surveillance *

* coming soon

How can we help you?

  • Do you need a new regulatory partner?
  • Are you starting from scratch?
  • Or do you just need some advice?

Start by talking with us so we can fully understand your requirements.

Your privacy is important. See how we handle your data.

Ask a question