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.
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PMCF Studies & Surveys
Design & implementation, fully compliant with EU MDR requirements
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Clinical Investigators
Ongoing PMCF system maintenance with adaptive clinical investigator & clinical site management
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Supporting Documents
PMCF Plans, Study Protocols, Evaluation Reports, Investigator's Brochures, ICFs & PILs to support your PMCF system
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Subject Matter Expertise
Benefit from the clinical knowledge of real medical professionals
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Tight Deadlines
We can expedite your project with no compromise on quality
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Fixed-Cost Pricing
Our collaborative proposals guarantee transparent pricing
Our Clients say
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.
DSRegulatory & 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:
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Study / Survey design protocol
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PMCF Plans and other documents
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Reporting and analysis mechanisms
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Data collection & handling processes
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Adverse Event capturing
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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.
Our Clients say
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.
ABQuality 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.
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Extensive database of clinical investigators
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Pre-approved for PMCF studies
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Rapid on-boarding & study initiation
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Access to a broad range of clinical sites
Our Clients say
A comprehensive, detailed and highly professional service.
BGRegulatory Manager Manufacturer, UK
Start today
- 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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