Oct 26, 2025Struggling to write benefit–risk language for ML SaMD that satisfies FDA reviewers without sounding promotional? In this lesson, you’ll learn how to use a regulatory voice and verb ladders to align claims with evidence, map benefits, risks, and uncertainties into modular sentence frames, and assemble concise, regulator-ready paragraphs. You’ll find clear explanations, annotated examples, and targeted exercises (MCQ, fill‑in‑the‑blank, error correction) to test and standardize your team’s phrasing. Expect an executive, practical toolkit you can adapt immediately for FDA/EMA submissions and internal reviews.

Oct 26, 2025Struggling to state plausible benefits without overpromising—or to name residual risks and uncertainty without alarming regulators? In this lesson, you’ll learn to craft regulator-ready narratives for AI/ML SaMD that tie probabilistic performance to clinical decisions, plainly articulate residual risks and uncertainties, and pair them with concrete mitigations and monitoring. You’ll find precise explanations, template-driven exemplars, and short practice items (MCQs, fill‑in‑the‑blank, error correction) to standardize your team’s voice across US/EU expectations. Finish with a one-paragraph, audit-traceable statement that stands up to FDA/EMA review and shortens review cycles.