Medical Device Regulatory Consulting Services

We bring subject matter expertise to your regulatory compliance

Dr Victoria Cartwright, Relationship Manager

Call us about our Consulting Services +44 114 299 2599 Call Monday-Friday 8am-8pm GMT

  • Clinical Evaluation

    • Subject Matter Expertise
    • CER & CEP Writers
    • Literature Reviews
    • Fixed-Cost Pricing
    • Notified Body Support
    • Tight Deadlines

    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 for Medical Devices service

  • Medical Writing

    • Clinical Evaluation Reports & Plans
    • Systematic Literature Reviews
    • PMCF Regulatory Documents
    • Subject Matter Expertise
    • Fixed-Cost Pricing
    • Tight Deadlines

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

    Learn more about our Medical Writing for EU MDR Compliance service

  • Clinical Evidence Generation

    • PMCF Studies & Surveys
    • Clinical Investigators
    • Supporting Documents
    • Subject Matter Expertise
    • Tight Deadlines
    • Fixed-Cost Pricing

    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 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 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?

Whatever your requirements, contact us today to start your free & confidential consultation.

Call Monday-Friday 8am-8pm GMT

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