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.
CEP & CER Writing Services with Guaranteed Notified Body Acceptance
Market-Leading Clinical Evaluation Consulting
- Fully Qualified CER Signatories
- Unlimited Post-Submission Support
- Guaranteed MDR Approval
Peace of mind during your Clinical Evaluation
- Expertly managed from start to finish
- Complete transparency throughout
- Named project lead + direct communication
Guaranteed Notified Body acceptance of your CEP & CER
- Unlimited start-to-finish support
- Guaranteed final Notified Body approval
- We are invested in your success
We design the most efficient route to CER approval
- Improved ROI through effective project plans
- Save time & money by eliminating errors
- We have experience over hundreds of CER submissions
Let's talk
Get in touch today to discuss your Clinical Evaluation requirements
A Forward-Thinking Clinical Evaluation Process
We have developed our successful UK & EU MDR Clinical Evaluation process to help get your medical device compliant first time.
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Technical file review
We will conduct a thorough review of all relevant technical files shared under a framework of confidentiality and IT security.
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Literature searches
Research questions and search terms are developed and initial searches are run in a minimum of 2 databases.
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Relevancy screening
A full relevancy screening is conducted against specified inclusion/exclusion criteria, duplicates are removed and all exclusions are tracked, recorded and justified.
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Literature review
The literature review team conducts appraisal and analysis according to specified search protocol.
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CER writing
Lead medical writers produce a 14-section CER using proven structure and integrating outputs of literature review.
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Client draft review
Draft submitted for review at your pace and capacity. A review call is then held, feedback collated and adjustments made.
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Finalised CER
The result is a professional, MDR-compliant CER meeting all relevant requirements and integrating systematic literature reviews.
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Post-submission
We then offer unlimited support with Notified Body reviews, standing 100% by our work and giving you complete peace of mind.
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Outcome
Our goal is first-time approval of your Clinical Evaluation documentation. Contact us to book your free, no-obligation consultation call.
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More Clinical Evaluation Services
If you are not starting from scratch we also have several related services that may suit your requirements.
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CER Review Service
We offer a full CER Review Service incorporating line-by-line analysis, detailed revision reports and full scope recommendations.
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NCR response & remedial work
If you have received a Non-Conformance Report for your CER submission, we are specialists in providing mitigating advice, alongside re-working documents and preparing responses to Notified Bodies.
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CEP + CERTemplates
Learn the secrets of our successful Clinical Evaluation process and become a confident writer of CEPs & CERs with our unique, peer-reviewed Clinical Evaluation templates.
Expert Literature Reviews for your 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.
How Mantra Systems can support your Clinical Evaluation
What you get with Mantra Systems…
- SOTA Literature Searches & Reviews
- Clinical Data Appraisal & Analysis
- Existing CER & CEP reviews
- Experts in all types & classes of medical device
- Personalised project plans to suit your needs
- Named project lead to support you throughout
- Flexible payment options with no hidden costs
- Unlimited post-submission support until approval
Are you looking for…
- Expert CER & CEP medical writers?
- A quote for our services?
- Help understanding your options?
Whatever you need, contact us today to start your free, no-obligation consultation.
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