PMCF Plans, Studies & Surveys

Powerful medical device Post-Market Clinical Follow-up systems designed by medical experts for EU MDR compliance

Our PMCF services

An effective Post-Market Clinical Follow-up system is an essential component of all regulatory frameworks under the MDR. We handle all aspects of PMCF system design and documentation while our curated EDC systems ensure simple, point-of-use data collection.

  • PMCF Plan, Study & Survey design

    Complete PMCF systems designed for your medical devices and built on MDR requirements.

  • Medical & Technical Document Writing

    PMCF Reports, Study Protocols & Evaluation Reports, Investigator's Brochures, ICFs & PILs.

  • Clinical site on-boarding & initiation

    Dedicated support to ensure efficient and effective clinical site activation.

  • Clinical data collection & storage

    PMCF eCRF & ePRO systems enabling GDPR-compliant data collection from any device.

  • Automated‚Ä® analysis & reporting

    Continuous, automated data monitoring & reporting throughout the entire lifetime of a device.

  • Study‚Ä® maintenance

    On-going PMCF Study & Survey maintenance with adaptive clinical site engagement.

Start today

Our in-house medical professionals have extensive experience developing tailored PMCF systems. Start with a free MDR support session so we can fully address your needs.

Book a free MDR support session with one of our team

Book now

Ask a question