Medical Writing for EU MDR Compliance

We offer complete Medical Writing services for all classes of medical device

Dr Paul Hercock, Chief Executive Officer

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

Regulatory documents written by medical doctors

Choose medical writers with professional clinical experience.

  1. Clinical Evaluation Reports & Plans

    Clinical Evaluation Reports & Plans

    CERs & CEPs written by medical experts to comply with the latest guidelines including MDR Annex XIV Part A

  2. Systematic Literature Reviews

    Systematic Literature Reviews

    Market-leading Literature Reviews for Clinical Evaluation, Risk Management and other MDR market access activities

  3. <abbr title='Post-Market Clinical Follow-up'>PMCF</abbr> Regulatory Documents

    PMCF Regulatory Documents

    PMCF Plans, Study Protocols, Evaluation Reports, Investigator's Brochures, ICFs & PILs to support your PMCF system

  4. Subject Matter Expertise

    Subject Matter Expertise

    Benefit from the clinical knowledge of real medical professionals

  5. Fixed-Cost Pricing

    Fixed-Cost Pricing

    Our collaborative proposals guarantee transparent pricing

  6. Tight Deadlines

    Tight Deadlines

    We can expedite your project with no compromise on quality

Ask us a question

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.

AK

Chief Executive Officer Manufacturer, France

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

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

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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