Define the evaluation strategy
Align the intended purpose, claims, device history, equivalence position, and applicable requirements before drafting begins.
Book a Scoping Call EU MDR Clinical Evaluation
Clinical 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.
The IMTS perspective
Evidence that stands up to scrutiny.
A Clinical Evaluation Report must connect the device, its intended purpose, the state of the art, clinical data, risk management, and postmarket evidence into one defensible evaluation. IMTS develops and updates CERs for medical device manufacturers navigating EU MDR requirements, notified body review, remediation, and recurring clinical evaluation cycles.
The strongest CER is not simply a compilation of studies. It explains why the available evidence is relevant, sufficient, and consistent with the device's benefit risk profile while making every conclusion traceable to its source.
Scope of support
What we can deliver.
- 01Clinical Evaluation Plans
- 02New and updated Clinical Evaluation Reports
- 03State of the art assessments
- 04Clinical evidence appraisal and gap analysis
- 05Notified body response and remediation support
How we work
A focused path from source evidence to final document.
Build the evidence base
Identify, appraise, and synthesize device, equivalent device, and state of the art evidence using a documented methodology.
Create a defensible narrative
Connect clinical evidence to safety, performance, benefit risk conclusions, and postmarket activities with clear traceability.
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.
Book a Scoping Call