An IVD, or in vitro diagnostic, is a medical device designed to examine specimens taken from the human body, such as blood, tissue, or saliva, to provide information for diagnosis, monitoring, or treatment decisions. In translation and localization, the term appears in product labels, instructions for use, technical files, performance evaluation reports, and regulatory submissions for diagnostic tests and instruments.
IVD translation projects typically include instructions for use, labels, software interfaces, reagent kit inserts, calibrator and control documentation, and technical documentation for regulatory approval. Translators must differentiate between sample types, test principles, result interpretations, and measurement units, because small wording changes can affect how a diagnostic result is read, reported, or acted upon in clinical settings.
A common error is translating IVD analyte names too freely, such as using a general term instead of the exact biomarker or reagent name, which can mislead users and break regulatory traceability. Another risk is confusing 'qualitative' and 'quantitative' result language or altering cutoff wording, changing how clinicians interpret a positive or reactive result.
FDA, CE/MDR and NMPA reviewers assess the submitted wording itself. Regulatory bodies require traceable, accountable translation, and an inconsistent term can delay or fail a submission.
Angel Translation locks terms like this into a project terminology base before expert review begins, so the same source term resolves to the same target term across every document in a submission — and stays consistent in the next revision. See the 8-step AI + expert workflow.
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