Initiation
We start by allocating you a dedicated medical writing / literature review team of regulatory experts and medical professionals with clinical experience in your device's field of use.
Clinical Evaluation for all classes of medical device
100% CER submission success rate from a international team of expert medical consultants
Find out more Or talk to us today
Need consulting support or a quote? Get in touch with us today
Professional CER & CEP writing for EU & UK market access
Our international team of over 50 subject matter experts are specialists in handling large projects producing multiple Clinical Evaluation Reports & Plans in parallel.
- CERs written for EU & UK MDR compliance
- For all classes of medical device in any clinical field
- Fully insured ISO & TOPRA-registered consultants
- Complete Meddev & MDCG compliant CER writing service
- Appropriately qualified CER signatories
- Scalable capacity servicing a worldwide client base from start-ups to multinationals
Complete CER writing service for all device types & classes
Our expert team of medically trained CER writers will bring unrivalled clinical evidence appraisal & analysis to your medical device Clinical Evaluations.
- New Clinical Evaluation Reports & Plans
- Updates to previous CERs & CEPs
- Review of existing Clinical Evaluations
- Literature search protocols & SOTA reviews to support CER production
- Responding to Non-Conformity Reports (NCRs)
- Working with tight deadlines & re-submissions
Our Clinical Evaluation promise
Dedicated CER specialists will ensure your medical devices are compliant, while being clear and transparent with you every step of the way.
- Rapid quote & set prices with no hidden extras
- Fixed timelines with a commitment to meet your deadlines
- Allocated project team & named primary contact
- Direct & constant visibility of project progress
- No final invoice until 100% client satisfaction
- Ongoing support after CER submission to Notified Body with no additional cost
Want to talk to an expert? Send us your details and we'll get back to you…
Our Clients say
Mantra Systems have provided outstanding quality literature search reports and State of the Art appraisals 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 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, UK Procter & Gamble
Our Clincial Evaluation process
We have developed our successful EU & UK MDR Clinical Evaluation process to help get your medical device compliant first time.
-
-
Technical file review
We will conduct a thorough review of all relevant technical files shared under a framework of confidentiality and IT security.
-
Literature searches
Research questions and search terms are developed and initial searches are run in a minimum of 2 databases.
-
Relevancy screening
A full relevancy screening is conducted against specified inclusion/exclusion criteria, duplicates are removed and all exclusions are tracked, recorded and justified.
-
Literature review
The literature review team conducts appraisal and analysis according to specified search protocol.
-
CER writing
Lead medical writers produce a 14-section CER using proven structure and integrating outputs of literature review.
-
Client draft review
Draft submitted for review at your pace and capacity. A review call is then held, feedback collated and adjustments made.
-
Finalised CER
The result is a professional, MDR-compliant CER meeting all relevant requirements and integrating systematic literature reviews.
-
Post-submission
We then offer unlimited support with Notified Body reviews, standing 100% by our work and giving you complete peace of mind.
-
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
-
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, France Manufacturer
-
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, UK Manufacturer
International team of subject matter experts
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:
- 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…
Clinical Evaluation in context
What is Clinical Evaluation?
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.
The challenge
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.
- Clinical Evaluation Report (CER) writing
- Literature searches & reviews
- Clinical data appraisal & analysis
- Validated 14-section CER structure
- Clinical Evaluation Plan (CEP) writing
- Post-submission Notified Body support
The importance of Literature Reviews in Clinical Evaluation
Well-conducted literature searches & reviews are at the heart of all successful CER submissions.
Requirements include:
- Developing and working to a Search Protocol meeting requirements in MedDev 2.7/1 rev 4
- Capturing all relevant evidence sources for SOTA and subject device
- Tracking all excluded sources with justifications
- Conducting objective appraisal of included sources
- Extracting safety & performance benchmarks from SOTA
- Conducting an analysis comparing evidence relating to subject device with benchmarks
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.
Related Clinical Evaluation services
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.
-
CER Review Service
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.
-
NCR response & remedial work
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.
-
CER Writing Training & Template
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.
Are you looking for…
- Clinical Evaluation consulting support?
- A quote for our services?
- Help understanding your options?
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