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AI can support PMCF and PMS documentation translation only as a controlled pre-translation step inside a workflow with qualified human review. Through aiHubLink, AbroadLink connects generative AI models with client terminology and previous approved translations, then applies medical-linguist review under ISO-based processes. For PMCF reports, PMS conclusions, PSURs, vigilance content, complaint summaries and trend analyses, AI output is always treated as a draft, not a finished post-market document. The client remains responsible for clinical, regulatory, vigilance, quality and post-market approval decisions. AI is positioned cautiously: useful where suitable, never a substitute for qualified human review.
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