Design Control设计控制
Design control is a documented system of procedures that governs medical device design and development from planning through design inputs, design outputs, verification, validation, and transfer to production. In quality system documentation it links documented user needs, risk management activities, and technical specifications throughout development so that the finished device can be shown to meet its intended use and specified requirements.
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Where this term appears
Design control terms appear in design and development plans, design input and output documents, traceability matrices, verification and validation reports, and design history files. Translators localizing technical files or regulatory submissions must keep these document types distinct so that evidence for each design phase remains traceable and reviewable across the submission.
Translation checks
A frequent mistake is translating “design verification” and “design validation” as the same word or reversing them. Verification asks whether design outputs meet specified inputs, while validation asks whether the device meets user needs and intended use; conflating them in a design history file can weaken the regulatory evidence chain.
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.