Clinical Evaluation for Medical Devices

We offer a full Clinical Evaluation service for all classes of medical device

Sandra Gopinath, Clinical Evidence Regulatory Specialist

Call us about our Clinical Evaluation services +44 114 299 2599 Call Monday-Friday 8am-8pm GMT

MDR-Compliant Clinical Evaluations

CERs, CEPs, Literature Reviews & Data Analysis by our clinically-active medical experts.

  1. Subject Matter Expertise

    Subject Matter Expertise

    Benefit from the clinical knowledge of real medical professionals

  2. CER & CEP Writers

    CER & CEP Writers

    Choose medical writers with professional clinical experience

  3. Literature Reviews

    Literature Reviews

    Expert appraisal & analysis of clinical evidence sources

  4. Fixed-Cost Pricing

    Fixed-Cost Pricing

    Our collaborative proposals guarantee transparent pricing

  5. Notified Body Support

    Notified Body Support

    We can engage with notified bodies after your CER submission

  6. Tight Deadlines

    Tight Deadlines

    We can expedite your project with no compromise on quality

Ask us a question

How it works

See how our Clinical Evaluation Service works from start to finish.

Our Clients say

All aspects of communication from Mantra Systems have been excellent from initial contact to the conclusion of the projects. There was excellent communication during the projects, included reviews and discussions helping to maintain the momentum and provide the required outcomes.

The work was performed to excellent standards with every part surpassing expectation. The final reports were of an impeccable standard that I am incredibly confident using going forward as part of my technical files.

DS

Regulatory & QA Manager Manufacturer, UK

Related services

We also have related Clinical Evaluation services that could assist your regulatory strategy.

Our Clients say

We engaged the services of Mantra Systems to support us with updating our Clinical Evaluation Reports both for MDR (UK) and MDR (EU). 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.

Regular meetings were implemented to ensure understanding of both parties and to discuss and address any findings within individual reports. We would engage the CER services again in the future should the need for further support arise.

PW

Head of Clinical Governance & Regulatory Affairs Manufacturer, UK

CER Clinic

Once a month, we run our free CER Clinic which gives you direct access to our medical writing team where you get the opportunity to ask them your CER-related questions.

What can you expect?

  1. Join us on a video call to ask any CER-related question
  2. Learn from the experience of others in the same situation
  3. Gain an understanding of common pitfalls and what to do to avoid them
  4. Develop insight into choosing services that match your requirements

Please note:
We will be scheduling our next CER Clinic date soon.

Need answers now?

If you can't wait and you'd like answers to your CER questions today, please feel free to ask us directly by contacting our team.

Our Clients say

A comprehensive, detailed and highly professional service.

BG

Regulatory Manager Manufacturer, UK

Start today

  • Do you need a new regulatory partner?
  • Are you starting from scratch?
  • Would you like a quote for our services?

Whatever your requirements, contact us today to start your free & confidential consultation.

Call Monday-Friday 8am-8pm GMT

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