Expert regulatory medical writing services by clinically-active healthcare professionals
Writing technical documents for medical device regulatory compliance is a skilled task that requires a wide range of skills.
Our medical writers produce documents & reports for effective EU MDR compliance
- PMCF Plans, Study Protocols, Evaluation Reports, Investigator's Brochures, ICFs & PILs to support your PMCF system.
- CERs & CEPs written by medical experts and comply with the latest guidelines & MDR Annex XIV Part A.
- Expert clinical evidence & systematic literature reviews for Clinical Evaluation, Gap Analysis and market access activities.
- Tailored technical documents meeting MDR requirements for specialist SaMD applications.
What 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 Medical Device Manufacturer, UK
Our clinically-active medical writers have clear communication skills, detailed subject matter expertise and a high-level ability to interpret and work with clinical evidence.
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