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.
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.
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.
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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