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.
Your Clinical Evaluation partner for full MDR approval
- Fully Qualified CER Signatories
- Unlimited Post-Submission Support
- All Device Types & Classes
Looking to produce compliant CEPs & CERs?
- We have experience over 250+ Clinical Evaluations
- An in-house team of medical doctors & regulatory experts
- CER writers with 100% approval under the UK & EU MDR
Guaranteed Notified Body acceptance
- Quality ensured by a money-back guarantee
- All risk classes & device types
- Dedicated start-to-finish support from a named project lead
Projects tailored to the needs of your devices
- Professional strategies to identify & remove risks
- Project plans to meet your deadlines
- Flexible payment options to suit your workflow
Let's talk
Contact us to book your free, no-obligation consultation call
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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 + CER Templates
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
Flexible Consulting Options
Tailored pricing to suit your needs
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Fractional Regulatory Consulting
Our team operate as a direct extension to yours on a rolling monthly basis.
- Best for…
- Lower initial costs & no long-term contract
- Tailored consulting based on identified needs
- Support throughout product lifetime
Starting from: £2,850
per month -
Project-Based Consulting
We'll work with you to create a project plan around your allocated budget.
- Best for…
- Fixed submission deadlines
- Known deliverables
- Overcoming acute capacity constraints
Enquire for pricing
Are you looking for…
- Expert CER & CEP medical writers?
- A quote for our services?
- Help understanding your options?
Whatever you need, contact us today for a same-day quotation.
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