Technical File技术文件
A technical file is a structured compilation of technical documentation showing that a medical device conforms to the relevant regulatory requirements, particularly for CE marking under European legislation. In translation and localization, it includes device descriptions, risk management files, clinical evaluation reports, labeling, and test results, and it must be organized for regulatory assessment by notified bodies or competent authorities.
Angel Translation editorial reference · Confirm the rendering against your source and approved project terminology.
Check source meaning → confirm the preferred term → record approved variants and references.
Where this term appears
Technical file translation is common in medical device submissions for CE marking, notified body reviews, and post-market obligations. Translators handle device descriptions, instructions for use, risk documentation, and clinical evidence, often working with templates that must be adapted to the target country without changing technical data or intended purpose.
Translation checks
One serious error is translating 'intended purpose' loosely, because it can change the device classification or regulatory scope. Another is inconsistency between the technical file and labeling or instructions for use. Missing or altered declarations and standards references can also trigger notified body questions, rejection, or requests for resubmission.
Keep the term aligned across your files
Check intended use, warnings, document versions and approved terminology with the project team. Translation supports documentation; it does not establish product approval or regulatory acceptance.
Provide approved terms and previous translations with the source files. Agree how variants, ambiguous wording and revisions will be reviewed. Terminology maintenance and any termbase handback are confirmed in the project scope. See the 8-step AI + expert workflow.
Related document experience
NIPRO Medical (Hefei)
Chinese → EnglishMedical-device registration files and technical specifications, in volume.
Read the published project →
Walvax Biotechnology
Chinese → EnglishQuality manuals, SOPs, production-process and clinical-trial documentation.
Read the published project →Published scope shows related industry experience; it does not confirm that this specific term was used or reviewed in the project.
Working on life science documentation?
Include the source and target languages, file types, intended use, deadline and any approved termbase. Agree handling before sending sensitive files. Acknowledged in 4 hours, quoted in 24.
Prepare an inquiry email →Life Science solutions →File handling →A glossary entry is not an official standard or evidence of regulatory acceptance. Confirm current requirements for your project separately.