Post-Market Clinical Follow-up Dynamic PMCF systems integrating people, data and devices

Powerful medical device registries and surveys designed by medical experts and driven by leading-edge technology.

Combining innovative design with the insight of medical experts

An effective Post-Market Clinical Follow-up (PMCF) system is an essential component of all regulatory frameworks under the MDR.

Our in-house medical professionals have years of clinical experience and extensive knowledge of study design techniques.

  • Professional PMCF study design

    Detailed knowledge of medical device registry and survey design techniques.

  • Real-time data collection & storage

    Curated eCRF, ePRO and data storage systems enabling secure data collection from any device.

  • Technical document writing

    PMCF Plans, Protocols, Investigator's Brochures, ICFs and PMCF Reports written by medical experts.

Our PMCF process

Mantra Systems' PMCF process

Our PMCF design service begins with a free consultation to discuss your requirements.

We then develop a tailored, individual proposal before commencing definitive study design and production of study protocols.

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Enhanced user experience ensures efficient data collection

Our team will develop a GDPR-compliant data collection system designed around the unique needs of your product, enabling investigators and patients to securely input data directly into the PMCF study.

Our curated EDC systems ensure simple, point-of-use data collection, enhancing data entry compliance and reducing time and money lost through missing data.

  • Site on-boarding support

    Individual support to ensure clinical sites are activated with minimal delay.

  • Study maintenance

    On-going registry and survey maintenance with adaptive clinical site engagement.

  • Automated PMCF Reporting

    Continuous, automated data monitoring and reporting throughout the entire lifetime of a device.

Call us now to discuss your MDR requirements:

(+44) 0114 386 3349

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MDR Consulting

Our team of medical doctors are specialists at building the clinical evidence portfolio that you need for MDR compliance of your products.

Download our free Mastering the MDR White Paper — An easily digestible summary of the EU MDR

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MDR Training

Our comprehensive training services are delivered by experts and address all aspects of MDR compliance.

MDR Guidance

Our unique MDR guidance resources are written by our medical experts and free to use. They cover all aspects of the new Medical Device Regulation.

Do you have any questions about our MDR services?

Contact us