IFU, 510(k) material, CE/MDR technical files, SOPs and clinical protocols — translated against the governing standard, with a documented and traceable process.
In a regulatory submission the text is not a wrapper around the evidence — it is part of the evidence. Reviewers read what you filed. An ambiguous rendering of an indication, a contraindication or a performance claim becomes a question to answer, and questions cost review cycles.
Regulated terminology is defined by the governing standard and by your own device labelling. A defensible synonym is still the wrong word if the standard and your label use another. Consistency with the source document set matters as much as linguistic quality.
A quality system requires a documented process with accountable steps. Text of unclear provenance — including unreviewed machine output — is difficult to defend during an audit, regardless of whether it happens to be correct.
Challenge An in-vitro diagnostics company entering the US market needed its full FDA registration documentation translated to a standard that would withstand regulatory review.
Solution Expert-led translation by reviewers with biomedical background, following a documented and traceable process, accompanied by a written quality-assurance letter.
Documentation for these companies was delivered by Angel Translation. Click through for project details.
Bilingual reference for terms that appear in this documentation.
“Documentation submitted to Europe for review is held to a very high standard. Angel recommended using English as the source language and having native-speaker translators handle it — the result met our expectations, and they were willing to take our experts’ feedback and revise patiently.”
Acknowledged in 4 hours, quoted in 24. Under NDA from the first upload.