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 by talking with us so we can fully understand your needs.

Get free MDR support from our expert medical team

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