Establish the surveillance framework
Define objectives, data sources, responsibilities, methods, thresholds, and reporting cadence for the device.
Book a Scoping Call EU MDR Postmarket Surveillance
Postmarket Surveillance Writing for Medical Devices
Medical device postmarket surveillance plans, reports, evidence synthesis, trend analysis, and regulatory documentation aligned with EU MDR.
The IMTS perspective
Evidence that stands up to scrutiny.
Postmarket surveillance should generate meaningful evidence about device performance and safety throughout the product lifecycle. IMTS helps medical device manufacturers translate complaints, vigilance, trend, literature, registry, and other real world information into structured regulatory documentation.
PMS documents must do more than list data sources. They need to explain what was assessed, what the data mean, whether new risks or trends emerged, and how the findings affect clinical evaluation, risk management, and PMCF.
Scope of support
What we can deliver.
- 01Postmarket Surveillance Plans
- 02Postmarket Surveillance Reports
- 03PMS evidence synthesis and traceability
- 04Complaint, vigilance, and trend summaries
- 05Clinical evaluation and risk management inputs
How we work
A focused path from source evidence to final document.
Evaluate the signals
Integrate qualitative and quantitative findings from relevant postmarket sources and assess their clinical meaning.
Close the lifecycle loop
Translate conclusions into clear inputs for CERs, PMCF, PSURs, risk management, and corrective action decisions.
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