Clinical evaluation report translation
CERs, clinical data and literature translated by linguists with clinical backgrounds — because a notified body reads your evidence exactly as written.
Your clinical evidence, read in another language
A clinical evaluation report (CER) is the document that argues your device is safe and performs as claimed, based on clinical data. Under the EU MDR it sits inside your technical file, and a notified body — the auditor that certifies your device for the EU market — reads it critically. When any part of that evidence chain crosses a language barrier, the translation becomes part of the evidence.
The failure modes are specific. A hedged conclusion in a source study that comes out stronger in translation. A confidence interval reformatted into ambiguity. An adverse event description that shifts severity because a clinical term was rendered with its everyday meaning. None of these read as errors to a lay reviewer — all of them are visible to a notified-body reviewer comparing your claims against your data.
What we translate in a clinical evidence package
- Clinical evaluation reports (CERs) and clinical evaluation plans
- Clinical study reports and summaries — protocols, amendments, investigator brochures
- Published literature — studies in German, French, Italian, Japanese or other languages that support (or must be appraised in) your evaluation
- Post-market clinical follow-up (PMCF) documents and post-market surveillance reports
- Summary of Safety and Clinical Performance (SSCP) — which for Class III and implantable devices must be publicly available in all EU official languages, including a section patients can understand
The SSCP is a special case: it combines clinical precision with a plain-language requirement. Our translators handle both registers — exact for the professional section, genuinely readable for the patient section — in the same document.
Precision is a process, not a talent
Clinical translation at Link Translation runs through our health-science practice group: native-language translators with medical or life-science backgrounds, assigned by device category. They work against a controlled term base so that terminology in the CER matches the IFU, the labeling and every study summary in the file. An independent second specialist reviews every file against the source. A separate QA pass verifies every number, unit, dosage and statistical value.
Machine translation has no place in the first draft of clinical evidence. Its output is statistically plausible, which is precisely the problem: it smooths over the distinctions — “may be associated with” versus “causes” — that clinical writing exists to preserve. We use technology where it helps (translation memory keeps recurring safety text identical across documents and reduces cost on updates) and humans where judgment is required, which in a CER is everywhere.
Built for the technical file
Deliverables map segment-by-segment to the source, so your regulatory team can trace any sentence back to the original. Revisions are quoted on what changed, not the full document. Since 2005 we have supported regulated manufacturers with a network of 500+ specialist translators across 30+ languages — and every engagement starts with a fixed quote within 24 hours.
Frequently asked questions
Who translates clinical evaluation content?
Native-language linguists from our health-science practice group with medical, pharmacology or life-science backgrounds, matched to your device category. A cardiology CER is not assigned to a generalist. Every file gets an independent second review by another specialist.
Can you handle the literature that supports the CER?
Yes. Published studies, investigator brochures, clinical study reports and post-market data often need translation into or out of English so the evidence chain is complete. We translate them against the same term base as the CER itself, so terminology stays consistent across the whole evidence package.
How do you keep statistical and clinical data accurate?
Numbers, units, confidence intervals and dosage values are checked in a dedicated QA pass, separate from the linguistic review. Values are never rounded or reformatted without flagging it. Where the source is ambiguous, we query you rather than guess.
How fast can a CER be turned around?
You get a fixed quote with a deadline within 24 hours. Large evidence packages are split across several specialists working against a shared term base and translation memory, so volume scales without losing consistency.