Regulatory English for AI/ML SaMD: Writing EU AI Act Alignment Statements for Clinical and Performance Files
Struggling to translate the EU AI Act into clean, audit-ready language for your CER/PER? In this lesson, you’ll learn to draft a concise, evidence-anchored alignment statement for AI/ML SaMD that maps risk, data governance, oversight, performance, transparency, and change control to your MDR/IVDR files—harmonized with US submissions. Expect precise guidance, a seven-block template, calibrated examples, and short exercises to validate tone, placement, and traceability. You’ll leave with a reusable, regulator-calibrated scaffold that reduces queries and speeds reviews.
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