Oct 26, 2025Struggling to turn “robust” claims into regulator-ready, evidence-backed prose for AI/ML SaMD? In this lesson, you’ll learn to write authoritative GMLP language that aligns with FDA CDRH and DHCoE expectations—using the Intent + Method + Evidence/Control template, calibrated tense, and traceable identifiers. You’ll find a clear framework, annotated examples, and a focused phrase bank, followed by quick checks and targeted exercises to lock in reviewer-aligned wording and accelerate submissions.

Oct 26, 2025Reviewer questions slowing your SaMD submission? This lesson equips you to write authoritative, reviewer‑aligned GMLP statements using a five-part scaffold—intent, method, evidence, control, traceability—so each claim maps cleanly to artifacts and survives audit. You’ll get plain‑English rules, a template phrase bank across training, validation, change management, postmarket monitoring, risk, and documentation, plus concise examples and exercises to confirm mastery. Expect regulator‑calibrated guidance that standardizes team voice, reduces queries, and accelerates decisions across FDA/EMA contexts.