Periodic Safety Update Reports (PSURs) become difficult very quickly when the underlying data is fragmented. If complaint data, PMCF outputs, CER updates, and internal review decisions sit in separate silos, the report turns into a last-minute compilation exercise rather than a meaningful assessment.
Qmed supports manufacturers with PSUR planning, drafting, update cycles, remediation, and review readiness for devices where PSUR is required. We help connect the evidence sources behind the report so the output is coherent, useful, and defensible.
What this service covers
Support can include identifying the applicable devices and reporting cycles, structuring inputs, reviewing complaint and vigilance data, integrating PMCF and CER outputs, drafting and revising the report, supporting internal review, and preparing the report for notified-body-facing scrutiny where relevant.
For some clients, the immediate need is authorship. For others, the PSUR challenge exposes upstream problems in PMS governance, evidence ownership, or data flow. Qmed can address both the reporting output and the underlying process weaknesses that affect it.
What a strong PSUR depends on
A strong PSUR depends on more than a well-written document. It depends on a functioning PMS system, clear review responsibilities, usable evidence sources, and a reporting cycle that is realistic for the portfolio and the organisation running it.
That is why PSUR support should not be treated as document production alone. The best work here links the report to the broader post-market system and improves the quality of the next cycle as well.
Talk to Qmed
Tell us which devices need PSUR support, what evidence inputs already exist, and whether you need help with one cycle or a more sustainable reporting model.