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
- 250+ successful submissions
- All device types & classes
- Clinical Evaluation specialists
Facing challenges producing compliant CEPs & CERs?
- Clinical Evaluation requirements are more demanding than ever
- Heightened Notified Body scrutiny & stricter evidence requirements
- Most common source of non-conformities and delayed CE-marking
How we can help
- MDR Clinical Evaluation service tailored to your requirements
- Experts at resolving non-conformities and managing resubmissions
- Ability to meet tight deadlines while ensuring compliance for all risk classes
- Capacity to work across multiple products and device families
Eliminate Clinical Evaluation concerns
- We deliver first-time approval through CEP & CER writing customised to your devices
- In-house medical writing team combining clinicians and regulatory experts
- Guaranteed delivery dates and Notified Body submission support
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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.
Get in touch now
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
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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
Get in touch now
One of our team will respond to you today.