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.
Updated
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
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.
Chinese document application
Design Control in context · design-control procedure
- English source
- Record the design input and the related output.
- Chinese rendering to review
- 记录设计输入及相关设计输出。
Illustrative wording only. Confirm the rendering against the actual source and approved project terminology.
Check the distinction in context
Inputs, outputs, review, verification and validation are separate concepts within the document set. Keep their Chinese labels stable and preserve the references linking them. Do not turn a design-review statement into evidence that a later test or approval was completed.
Check the returned Chinese file
Select one design input and follow it through the Chinese index to the named output. Preserve the source stage and record reference so a reviewer can see which development activity the document actually records.
Prepare the connected files
Include the procedure, linked forms and approved development terminology. State whether the quote covers one procedure or reconciliation across the design records.
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 → EnglishVaccine-production process documentation, SOPs, quality-control standards and microbiology-testing procedures.
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.