Design History File设计历史文档
A design history file is a compilation of records that demonstrate a medical device was designed according to approved plans and requirements, including design inputs, outputs, reviews, verification, and validation. In translation, it appears in device regulatory submissions and quality system documentation, especially for markets requiring evidence of design control, and it is understood as a maintained file rather than a one-time report.
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 history file translation occurs during medical device regulatory submissions, technical documentation for notified bodies, and quality audits. The source text may include design plans, risk analyses, test protocols, and verification reports. Translators must keep terminology aligned with the design control system and the target market’s documentation expectations.
Translation checks
A common mistake is treating design history file as a single report rather than a compilation of records, which can distort how sections are cross-referenced. Translating verification and validation as the same term is also risky because they have distinct meanings. Inconsistent headings or numbering can make the file difficult to audit.
Chinese document application
Design History File in context · design-history file
- English source
- Link the design-review record to the design-history file.
- Chinese rendering to review
- 将设计评审记录关联至设计历史文件。
Illustrative wording only. Confirm the rendering against the actual source and approved project terminology.
Check the distinction in context
A file may be an organized record set rather than a single document. Clarify the source organization and preserve the record links. Chinese headings should distinguish the file index from the records it lists and from a technical submission package.
Check the returned Chinese file
Inspect the Chinese index as a navigation document. Record names and links should lead to the corresponding supplied files, and an index translation should remain distinguishable from translation of the underlying record set.
Prepare the connected files
Send the index, representative records and the approved naming convention. Identify which documents are in scope before the file list is priced as a complete set.
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
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Walvax Biotechnology
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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.