Book a Scoping Call EU MDR Medical Writing
Integrated EU MDR medical writing for CERs, PMCF, PMS, PSURs, SSCPs, literature reviews, and clinical evidence documentation.
Specialist document services
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
Indus MedTech Solutions is a medical-device-focused medical and regulatory writing company. We help manufacturers develop and maintain EU MDR clinical evaluation and postmarket documents as one connected evidence system rather than as isolated reports produced by different teams.
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.
Direct answers
IMTS writes Clinical Evaluation Plans and Reports (CEP/CER), Post-Market Surveillance Plans and Reports, PMCF Plans and Evaluation Reports, Periodic Safety Update Reports (PSUR), Summaries of Safety and Clinical Performance (SSCP), and supporting systematic literature reviews.
We align the device description, intended purpose, claims, clinical evidence, risks, benefit-risk conclusions, postmarket findings, and future evidence commitments across the CER, PMS, PMCF, PSUR, SSCP, labeling, and related source documents.
Manufacturers engage IMTS for new submissions, recurring updates, portfolio programs, remediation after notified body findings, evidence-gap assessment, and temporary writing capacity when internal clinical or regulatory teams need specialized support.
IMTS combines medical-device specialization, more than 300 CERs authored, advanced-degree writers, and boutique accountability. Our work is designed to create traceable conclusions that can be reviewed efficiently by internal teams and notified bodies.
Scope of support
How we work
Identify the required documents, source records, dependencies, review cycle, and stakeholder responsibilities.
Use consistent device descriptions, claims, risk conclusions, clinical data, and postmarket findings across deliverables.
Strengthen traceability, resolve gaps, and support responses when notified body questions require focused revision.
Related IMTS perspective
A practical IMTS framework for controlling shared evidence, risks, conclusions, and postmarket commitments across the EU MDR document lifecycle.
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We will help define the scope, source materials, review process, and practical next step.
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