Map the document ecosystem
Identify the required documents, source records, dependencies, review cycle, and stakeholder responsibilities.
Book a Scoping Call EU MDR Medical Writing
EU MDR Medical and Regulatory Writing Services
Integrated EU MDR medical writing for CERs, PMCF, PMS, PSURs, SSCPs, literature reviews, and clinical evidence documentation.
Specialist document services
Explore EU MDR Medical Writing services.
01Clinical Evaluation Report Writing for Medical Devices
Reviewer ready Clinical Evaluation Report writing for medical devices, supported by rigorous literature review, evidence appraisal, and regulatory traceability.
Explore service 02Postmarket Surveillance Writing for Medical DevicesMedical device postmarket surveillance plans, reports, evidence synthesis, trend analysis, and regulatory documentation aligned with EU MDR.
Explore service 03PMCF Plan and Evaluation Report Writing ServicesPMCF writing services for medical devices, including PMCF Plans, PMCF Evaluation Reports, survey strategies, evidence gaps, and EU MDR alignment.
Explore service 04PSUR Writing Services for Medical DevicesPeriodic Safety Update Report writing for medical devices with integrated sales, complaints, vigilance, trend, CAPA, PMCF, and clinical evidence analysis.
Explore service 05SSCP Writing Services for Medical DevicesSummary of Safety and Clinical Performance writing for implantable and Class III medical devices with clear, consistent EU MDR evidence communication.
Explore serviceThe IMTS perspective
Evidence that stands up to scrutiny.
EU MDR documentation works as a connected evidence system. IMTS supports manufacturers across clinical evaluation, postmarket surveillance, PMCF, periodic reporting, and public facing safety summaries so that conclusions remain aligned across the technical documentation.
Disconnected documents create avoidable inconsistencies in claims, evidence, risk conclusions, and postmarket commitments. Our writers preserve a coherent clinical story across the documents reviewed by notified bodies.
Scope of support
What we can deliver.
- 01Clinical Evaluation Plans and Reports
- 02Postmarket Surveillance Plans and Reports
- 03PMCF Plans and Evaluation Reports
- 04Periodic Safety Update Reports
- 05Summaries of Safety and Clinical Performance
How we work
A focused path from source evidence to final document.
Align the evidence
Use consistent device descriptions, claims, risk conclusions, clinical data, and postmarket findings across deliverables.
Prepare for review
Strengthen traceability, resolve gaps, and support responses when notified body questions require focused revision.
Start a conversation
Bring us the document that needs to move forward.
We will help define the scope, source materials, review process, and practical next step.
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