Initiation
We start by allocating a dedicated project team of regulatory experts and medical professionals with clinical experience in your device's field of use.
Comprehensive design & management of PMCF systems supporting all classes of medical device for EU & UK market access
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Mantra Systems offers a complete and customisable PMCF service, supporting you every step of the way.
Our international network of over 50 clinically-active medical professionals will drive investigator engagement, ensuring ongoing compliant data collection.
Optimised PMCF systems that receive rapid approval from investigators, while providing a seamless & transparent collaboration experience.
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A comprehensive, detailed and highly professional service.
BGRegulatory Manager Manufacturer, UK
We have developed a successful MDCG & MDR compliant PMCF service to ensure the best system is created for your medical device.
We start by allocating a dedicated project team of regulatory experts and medical professionals with clinical experience in your device's field of use.
Before making recommendations on study design, the assigned project team will analyse your Clinical Evaluation, PMS and Risk Management files to define residual uncertainties on device safety or performance.
Residual uncertainties and device characteristics drive study type (survey, clinical study, registry, etc) and datapoint selection. Initial system design is presented to you for review.
Close collaborative working with you means rapid iteration and revision of the initial design, ensuring harmonisation with expectations and requirements.
Once system design is finalised, our professional medical writers will develop your PMCF Plan along with essential study technical documents including protocol / CIP, investigator's brochure, DPA, DEA, ICF, PIL, etc.
Electronic Data Capture (EDC) forms will be developed by user experience experts using a certified, market-leading system, enabling data input from remote clinical sites using any computer, tablet or smartphone.
Our team are experts at facilitating rapid study approvals and investigator onboarding, reducing the time to data collection.
Continuous monitoring of study progress, recruitment rates, protocol adherence and interim data trends, while ensuring use of pseudonymised outputs for full GDPR compliance.
Scrutiny and analysis of collected data and production of interim, annual and final study PMCF Evaluation Reports.
Our goal is full approval of your devices. Get in touch with our team for a free, confidential & no obligation discussion.
All aspects of communication from Mantra Systems have been excellent from initial contact to the conclusion of the work. There was excellent communication during the projects, included reviews and discussions helping to maintain the momentum and provide the required outcomes.
DSRegulatory & QA Manager Manufacturer, UK
Your service surpassed our expectations and added value across our organisation. We feel much better placed to prepare for the MDR.
KWChief Executive Officer SaMD Company, UK
PMCF is a proactive data collection activity that forms one arm of Post-Market Surveillance (PMS), alongside Vigilance processes. Under the EU MDR, the main purpose of PMCF is to collect data relating to residual uncertainty on device safety or performance.
While it has long been a requirement to conduct PMCF activities, the enactment of the EU MDR gave PMCF heightened prominence and broadened the circumstances in which PMCF must be conducted.
In short, unless you have a device with a long, well-established market history that has remained unchanged for most of its clinical life, it's likely that some form of PMCF will be required.
Mantra Systems has solved these challenges. Working with us will get you optimised PMCF system design, rapid approvals and ongoing investigator engagement.
PMCF study technical documents include:
It is mandatory to produce a PMCF Plan outlining how PMCF activities will be performed. In the event of a formal survey, registry or clinical study, it is also a requirement to ensure alignment with requirements on PMCF study documentation.
MDR Annex XV contains a list of requirements for clinical investigation documents which, as relevant, must be adhered to.
Mantra Systems are experts in producing compliant technical documents across a range of surveys and PMCF study types, with successfully implemented PMCF studies across a multitude of device types and classes.
It was a pleasure working with you. We are completely satisfied with your service and look forward to working with you again.
JFChief Executive Officer SaMD Company, Denmark
We serve an international client-base covering all classes of medical device across a wide range of clinical fields.
Our clients are based around the world, hailing from the UK, Europe, North America, Central America, Asia and the Middle East, and vary in size from pre-market start-ups to stockmarket-listed multinationals.
Mantra Systems have worked hard to meet our specific needs and have been a pleasure to work with; I would thoroughly recommend them.
TDDr. Trevor Day Principal Scientist Procter & Gamble, UK
Mantra Systems has a dynamic team of subject matter experts with an extensive knowledge of PMCF study design.
Our team includes an international network of active clinicians who are experienced clinical investigators and specialists in their field, along with regulatory professionals and user interface specialists with over 20 years of experience.
We offer an unparalleled ability to design PMCF systems with maximum utility while removing all barriers to ongoing investigator engagement. We'll ensure that datapoints are optimised, study interfaces are simple, and approvals are quick and efficient.
Mantra Systems also comprises professional medical writers and clinical data analysts, driving the development of MDR Annex XV and ISO 14155:2020-compliant study technical documents, efficient data analysis, and production of compliant PMCF Evaluation Reports. This in-house expertise will ensure that the challenges of data scrutiny and document production are met while guaranteeing complete objectivity.
We match each project to subject matter experts who work within the clinical field of the device under evaluation, along with experienced regulatory professionals to lead the project.
Our 50 clinical experts based in the UK, Europe, USA, Canada, South Africa, and India.
Their specialities include:
The nature of our extended team also means we can scale resources to handle a project of any size.
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
Whatever you need, contact us today for a free & confidential discussion.
Mantra Systems provides professional EU & UK MDR medical device regulatory consulting services to companies seeking compliance & market access for any class of medical device.
Our international team of medically-trained consultants will bring unrivalled clinical evidence appraisal & analysis to your medical device regulatory strategy.