PMCF Studies, Surveys & Plans
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 many 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 Study Survey & Plan 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 analysis & reporting
Continuous, automated data monitoring & reporting throughout the entire lifetime of a device.
On-going PMCF Study & Survey maintenance with adaptive clinical site engagement.
Our in-house medical professionals have extensive experience developing tailored PMCF systems. Start by talking with us so we can fully understand your needs.