Plan the data collection
Define the reporting scope, period, device grouping, data owners, source tables, and reconciliation needs.
Book a Scoping Call Periodic Safety Update Reporting
PSUR Writing Services for Medical Devices
Periodic Safety Update Report writing for medical devices with integrated sales, complaints, vigilance, trend, CAPA, PMCF, and clinical evidence analysis.
The IMTS perspective
Evidence that stands up to scrutiny.
A PSUR is a periodic evaluation of the device's postmarket safety and performance, not a collection of departmental summaries. IMTS integrates exposure, incidents, complaints, trends, corrective actions, literature, PMCF, and benefit risk conclusions into a coherent report.
The reporting period may draw data from multiple owners, systems, regions, and product variants. Strong PSUR writing requires disciplined data reconciliation and a clear explanation of whether the overall benefit risk determination remains supported.
Scope of support
What we can deliver.
- 01New and recurring PSURs
- 02Data request and source mapping
- 03Exposure and sales data presentation
- 04Complaint, vigilance, trend, and CAPA synthesis
- 05Benefit risk and lifecycle conclusion updates
How we work
A focused path from source evidence to final document.
Analyze the reporting period
Evaluate exposure, events, complaints, trends, corrective actions, literature, and PMCF findings in context.
Support the conclusion
Explain the implications for benefit risk, clinical evaluation, PMS activities, labeling, and future actions.
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