Clinical Evidence Generation
PMCF systems & clinical investigators for medical device regulatory compliance
An effective PMCF (Post-Market Clinical Follow-up) system is essential for ongoing approval of most medical devices under the EU MDR.
We design & initiate PMCF systems to generate clinical evidence
- PMCF study / survey design and implementation, fully compliant with EU MDR requirements.
- GDPR-compliant data collection and secure storage using online eCRF & ePRO systems, enabling real-time data input from any device.
- Lifetime monitoring of device usage with automated clinical data generation & reporting used for Clinical Evaluation and other areas of your MDR strategy.
- Ongoing PMCF system maintenance with adaptive clinical investigator management.
- Medical document writing including PMCF plans & reports, study protocols & evaluation reports, investigator's brochures, ICFs & PILs.
All aspects of communication from Mantra Systems have been excellent from initial contact to the conclusion of the projects. There was excellent communication during the projects, included reviews and discussions helping to maintain the momentum and provide the required outcomes.
The work was performed to excellent standards with every part surpassing expectation. The final reports were of an impeccable standard that I am incredibly confident using going forward as part of my technical files.DS
Regulatory & QA Manager Manufacturer, UK
Unsure whether you need PMCF?
Our PMCF Checker is a quick test to see if your medical device needs a PMCF system for regulatory compliance.
Free PMCF Audit
We offer a free PMCF audit service where we review your existing Post-Market Clinical Follow-up system and produce a comprehensive report with guidance and advice. We audit:
Study / Survey design protocol
PMCF Plans and other documents
Reporting and analysis mechanisms
Data collection & handling processes
Adverse Event capturing
Alignment with Meddev & MDCG guidelines
Please contact a member of our team to discuss this service in more detail.
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
Our extensive clinical evidence generation experience will enable us to develop the PMCF system your medical device needs for regulatory compliance.
Start your free and confidential consultation by contacting us today.
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