100% guaranteed Notified Body approval for CERs & CEPs under UK & EU MDR
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Do you need a Medical Device Clinical Evaluation quote? Get in touch with us today
We are building on our 100% CER submission success rate to offer a unique guarantee — full Notified Body approval of any CER prepared by us, or your money back.
Our expert team of medically trained CER writers bring unrivalled clinical evidence appraisal & analysis to your medical device Clinical Evaluations.
Overcome the key step in medical device approval with complete confidence, ensuring market access for your devices in the UK & EU.
We guarantee that any CER written through our CER Assurance Service will meet full Notified Body acceptance, or your money back.
This unique offer is restricted to 5 new clients each month due to the intensive resources required. Speak with a member of our team today to avoid missing out.
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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
We have developed our successful EU & UK MDR Medical Device Clinical Evaluation Assurance process to help get your medical device compliant first time.
We begin by conducting a FREE CER readiness evaluation, ensuring you avoid any costs in the event that key information is missing. Once complete, we allocate a dedicated medical writing / literature review team of regulatory experts and medical professionals with clinical experience in your device's field of use.
We will conduct a thorough review of all relevant technical files shared under a framework of confidentiality and IT security.
Research questions and search terms are developed and initial searches are run in a minimum of 2 databases.
A full relevancy screening is conducted against specified inclusion/exclusion criteria, duplicates are removed and all exclusions are tracked, recorded and justified.
The literature review team conducts appraisal and analysis according to specified search protocol.
Lead medical writers produce a 14-section CER using proven structure and integrating outputs of literature review.
Draft submitted for review at your pace and capacity. A review call is then held, feedback collated and adjustments made.
The result is a professional, MDR-compliant CER meeting all relevant requirements and integrating systematic literature reviews.
We offer unlimited support with any Notified Body questions, ensuring complete acceptance after final review or 100% of your money back.
Our goal is full approval of your devices. Get in touch with our team for a free, confidential & no obligation discussion.
I really appreciated your job on our medical device CER. It was truly amazing how you managed to get all this done in such a short notice. I'm very pleased with your work.
AKChief Executive Officer Manufacturer, France
The work was performed to excellent standards with every part surpassing expectation. The final Clinical Evaluation 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
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.
A comprehensive, detailed and highly professional service.
BGRegulatory Manager Manufacturer, UK
We engaged the services of Mantra Systems to support us with updating our CERs for multiple devices both for the EU & UK MDR. From start to finish the engagement and communication has been proactive and timely, keeping us updated throughout the entire process, and the quality of the reports fully met our needs.
PWHead of Clinical Governance & Regulatory Affairs Manufacturer, UK
Mantra Systems are specialists in handling large projects producing multiple CERs & CEPs in parallel.
Our international team of subject matter experts are active healthcare clinicians who are specialists in their field. They offer an unparalleled ability to critically evaluate the safety and performance of a medical device, with specific insight into how the device directly impacts patient care. The nature of our distributed team also means we can scale resources to handle a project of any size.
We match projects to a subject matter expert who works within the clinical field of the device under evaluation, providing the perfect foundation for a medical device Clinical Evaluation Report.
We have over 50 subject matter experts based in the UK, Europe, USA, Canada, South Africa, and India. Their specialities include:
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
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
Clinical Evaluation is a systematic and planned process to assess the safety and performance of a medical device.
The objective is to demonstrate conformity with the relevant Annex I General Safety and Performance Requirements (GSPRs), suitability for intended purpose, and that the device's benefit-risk profile continues to be acceptable.
Clinical Evaluation of each medical device is summarised periodically in a Clinical Evaluation Report (CER), with the periodicity determined by the risk class of the device.
Performing a Clinical Evaluation is no small undertaking. Writing MDR-compliant CERs and CEPs calls for a combination of skills and expertise, along with real proficiency when working with clinical evidence.
If that wasn't enough, it is often performed against looming submission deadlines, previous NCRs, and a changing regulatory environment.
The process of combining all the aspects of Clinical Evaluation into an MDR-compliant Clinical Evaluation Report may seem daunting. It is a formidable process which calls for a combination of skill and expertise.
We can assist you with all aspects of Clinical Evaluation including CERs, CEPs, Literature Searches & Reviews and Data Analysis.
Our core team of professional medical writers work with our specifically trained network of clinically active medical doctors, bringing the highest standards of clinical evidence appraisal and analysis.
Well-conducted literature searches & reviews are at the heart of all successful CER submissions.
Requirements include:
The correct approach calls for a detailed understanding of the clinical field and a natural ability to work with clinical evidence.
Our unique approach provides direct access to subject matter experts who scrutinise clinical evidence in their field, alongside experienced medical writers focused 100% on Clinical Evaluation.
If you're not starting from scratch or would like to perform your Clinical Evaluations in-house, we also have several related services that may suit your requirements.
Already have a CER draft and need an expert review before submission? We offer a full CER Review Service incorporating line-by-line analysis, detailed revision reports and full scope recommendations.
Received a Non-Conformance Report relating to a CER submission? Our team has extensive experience in making necessary changes, re-working documents and preparing responses to Notified Bodies.
Learn the secrets of our successful Clinical Evaluation process and become a confident writer of CERs with our online CER Writing Training Course. This is complimented by our unique, peer-reviewed CER Template.
Contact us to discuss any of these services in more detail.
Mantra Systems have provided outstanding quality literature search reports and State of the Art appraisal reports for our Oral Care Medical Devices. Mantra Systems have worked closely with us to allow our pre-existing Clinical Evaluation Report structures to be updated by them, thus minimizing document structure changes observed by our Notified Body. The reports delivered by Mantra Systems have fully met our needs and those of our Notified Body. 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
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.