Post-market surveillance is the set of activities a manufacturer uses to collect, analyze, and act on safety and performance data after a medical device or product is placed on the market. In translation and localization, it appears in PMS plans, periodic safety update reports, vigilance reports, post-market clinical follow-up documentation, and regulatory submission updates that describe how the manufacturer monitors ongoing safety and performance.
Post-market surveillance appears in regulatory submission annexes, PMS plans, periodic safety update reports, and vigilance system documentation for medical devices and medicinal products. Translators must keep terms like “complaint,” “incident,” “serious adverse event,” and “trend” distinct, because misclassification can change reporting obligations or risk conclusions.
A common error is translating PMS terminology too broadly, merging “adverse event,” “incident,” and “complaint” into one word. That can erase regulatory distinctions and make reports look incomplete or inaccurate. Translating “surveillance” as “monitoring” may also be acceptable in context, but the chosen term must match the client’s quality system and local regulatory usage.
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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