Clinical Evidence Generation
We design & build PMCF Studies & Surveys for all classes of medical device
Call us about our Clinical Evidence Generation services +44 114 299 2599 Call Monday-Friday 8am-8pm GMT
GDPR-Compliant Clinical Data Generation
Powerful PMCF Studies / Surveys & Clinical Investigators for EU MDR compliance.
PMCF Studies & Surveys
Design & implementation, fully compliant with EU MDR requirements
Ongoing PMCF system maintenance with adaptive clinical investigator & clinical site management
PMCF Plans, Study Protocols, Evaluation Reports, Investigator's Brochures, ICFs & PILs to support your PMCF system
Subject Matter Expertise
Benefit from the clinical knowledge of real medical professionals
We can expedite your project with no compromise on quality
Our collaborative proposals guarantee transparent pricing
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
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.
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.
Please thank all of your team for their brilliant efforts. Your standard of service, response time, and rigour were outstanding and I would strongly recommend you to any other potential client.AB
Quality Advisor Manufacturer, UK
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
A comprehensive, detailed and highly professional service.BG
Regulatory Manager Manufacturer, UK
- 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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