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.
Post-Market Clinical Follow-up Studies, Surveys & Plans
Comprehensive design & management of PMCF systems supporting all classes of medical device for EU & UK market access
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PMCF is an essential activity for medical devices & has never been so important
Mantra Systems offers a complete and customisable PMCF service, supporting you every step of the way.
- PMCF system design & implementation tailored to your medical device
- Writing PMCF plans, study protocols, investigator's brochures & more
- GDPR-compliant data collection & storage with ISO certified EDC systems
- Study site on-boarding & ethics committee engagement
- Adverse events management
- Data analysis & generation of PMCF Evaluation Reports
- Ongoing study maintenance & site management
PMCF design engineered for efficient implementation
Our international network of over 50 clinically-active medical professionals will drive investigator engagement, ensuring ongoing compliant data collection.
- Unique insight on PMCF design from real clinical investigators
- Study processes & systems optimised for end-user usability
- Efficient onboarding process for rapid approvals & implementation
- Real time performance monitoring & protocol violation management
- Direct clinician-to-clinician support
- Integration with Risk Management & Quality Management Systems
We guarantee
Optimised PMCF systems that receive rapid approval from investigators, while providing a seamless & transparent collaboration experience.
- Tailored quote with set prices with no hidden extras
- Fixed timelines with a commitment to meet your deadlines
- Allocated project team & named primary contact
- Direct access & transparency of project progress
- No final invoice until 100% client satisfaction
- Unlimited & free assistance with notified body review
Want to talk to an expert? Send us your details and we'll get back to you…
Our Clients say
Mantra Systems Ltd. authored an excellent and thorough Clinical Evaluation Report (CER) for our medical device, according to both UK & EU MDR, which was delivered on time. I was highly impressed by their expertise and professionalism throughout and wouldn't hesitate to work with them again.
MHMonica Hodgkinson Regulatory Compliance Manager, UK GV Health Ltd
Our PMCF process
We have developed a successful MDCG & MDR compliant PMCF service to ensure the best system is created for your medical device.
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Residual risk & uncertainty analysis
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.
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Initial system design
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.
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Design refinement
Close collaborative working with you means rapid iteration and revision of the initial design, ensuring harmonisation with expectations and requirements.
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Document production
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.
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Data capture system development
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.
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Site selection & onboarding
Our team are experts at facilitating rapid study approvals and investigator onboarding, reducing the time to data collection.
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Study oversight & maintenance
Continuous monitoring of study progress, recruitment rates, protocol adherence and interim data trends, while ensuring use of pseudonymised outputs for full GDPR compliance.
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Data analysis & reporting
Scrutiny and analysis of collected data and production of interim, annual and final study PMCF Evaluation Reports.
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Outcome
Our goal is full approval of your devices. Get in touch with our team for a free, confidential & no obligation discussion.
Our Clients say
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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, UK Manufacturer
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Your service surpassed our expectations and added value across our organisation. We feel much better placed to prepare for the MDR.
KWChief Executive Officer, UK SaMD Company
International team of medical experts & TOPRA registered RA professionals
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:
- Anaesthetics
- Cosmetic surgery
- Elderly care
- Emergency medicine
- General practice / family physician
- Intensive care
- Internal medicine
- Maxillofacial surgery
- Obstetrics / gynaecology & neonatal care
- Ophthalmology
- Orthopaedics
- Rheumatology
- Upper & lower GI surgery
- And many more…
The nature of our extended team also means we can scale resources to handle a project of any size.
PMCF in context
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.
The challenges
Here are just a few of the challenges facing medical device manufacturers trying to implement PMCF. Read more about PMCF challenges in our 3-part article series on PMCF under the EU MDR.
- 1. Longterm activity
- PMCF must be conducted throughout the clinical lifetime of the device, meaning any mistakes made during early design decisions can compound over time, escalating costs and producing poor data.
- 2. Study approval difficulties
- With clinicians under more pressure than ever, obtaining investigator 'buy in' can be extremely difficult.
- 3. Choosing the right approach
- PMCF systems can range in complexity, so it's vital to ensure the most appropriate form of data collection method is selected and implemented in an efficient and future-proof way from the start.
Mantra Systems has solved these challenges. Working with us will get you optimised PMCF system design, rapid approvals and ongoing investigator engagement.
The importance of well-written PMCF technical documents
PMCF study technical documents include:
- Protocol / Clinical Investigation Plan (CIP): Outlines how the study will be conducted, how data will be analysed, sample size justification, analysis plan, key responsibilities and management of adverse events.
- Investigator's Brochure: An extract of the CIP with a focus on responsibilities for Principal Investigators and sub-investigators during conduct of the study.
- Informed Consent Form (ICF): A means by which study subjects can indicate their GDPR consent for entry of their data into a PMCF activity.
- Patient Information Leaflet (PIL): A document intended to be read by potential study subjects outlining what participation would involve and, crucially, what will be done with their data.
- Data Processing Agreement (DPA): A specific agreement relating to the handling and processing of confidential data, outlining responsibilities for each party to the study.
- Device Evaluation Agreement (DEA): A contract intended to form an agreement between study sponsor and clinical sites for conduct of the study and any associated remuneration.
- Study Site Questionnaire (SSQ): A questionnaire to be completed prior to approval of study sites, ensuring all enrolled sites meet minimum requirements outlined in the protocol.
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.
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, UK Manufacturer
Are you looking for…
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Whatever you need, contact us today for a free & confidential discussion.
Our Clients say
Mantra Systems have provided outstanding quality literature search reports and State of the Art appraisals for our medical devices; I would thoroughly recommend them.
TDDr. Trevor Day Principal Scientist, UK Procter & Gamble