A CER is not only a document that has to exist. It needs to stand on a methodologically sound clinical evaluation, clear claims, traceable data sources, and a broader documentation package that supports the same story.
Qmed supports manufacturers with new CERs, CER updates, remediation work, and the clinical-evaluation activities that sit behind the final report. The aim is not simply to produce a report. It is to produce a CER that can be defended in context.
What this service covers
Support can include reviewing the current clinical-evaluation approach, identifying gaps, shaping the evaluation plan, carrying out or coordinating literature and data-review activities, writing or updating the CER, and aligning it with risk management, intended purpose, labelling, PMCF, PMS, and the wider technical documentation.
Where the issue is not only the report itself, Qmed can also help resolve the upstream problem — for example where the claims are too broad, the evidence strategy is weak, or the post-market interface has not been built into the evaluation properly.
What a strong CER depends on
A strong CER depends on more than well-written prose. It depends on a defensible evidence strategy, a clear understanding of the device and its intended use, transparent appraisal of the available data, and an honest view of limitations and remaining evidence needs.
That is why CER work should not be separated from Clinical Development, PMCF planning, and the wider technical documentation. The stronger the interfaces are, the stronger the report tends to be.
Typical situations
Most often, medtech innovators come to us with one or more of the following challenges:
- they need a new CER or a major update before a regulatory milestone
- the current CER feels weak because the evidence logic behind it is weak
- the CER has to be aligned with PMCF, PMS, labelling, or technical documentation changes
- they have notified-body feedback or internal concerns that point to remediation work
- they need an experienced team that can write, review, and challenge the logic behind the report
Talk to Qmed
Tell us whether you need a new CER, an update, remediation support, or help aligning the report with the wider regulatory file.