Medical Writing for EU MDR Compliance
We offer complete Medical Writing services for all classes of medical device
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.
Clinical Evaluation Reports & Plans
CERs & CEPs written by medical experts to comply with the latest guidelines including MDR Annex XIV Part A
Systematic Literature Reviews
Market-leading Literature Reviews for Clinical Evaluation, Risk Management and other MDR market access activities
PMCF Regulatory Documents
PMCF Plans, Study Protocols, Evaluation Reports, Investigator's Brochures, ICFs & PILs to support your PMCF system
Subject Matter Expertise
Benefit from the clinical knowledge of real medical professionals
Our collaborative proposals guarantee transparent pricing
We can expedite your project with no compromise on quality
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
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?
- Join us on a video call to ask any CER-related question
- Learn from the experience of others in the same situation
- Gain an understanding of common pitfalls and what to do to avoid them
- Develop insight into choosing services that match your requirements
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.
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
- 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.
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