Terminology Governance for SaMD: Acronym Expansion Rules for Regulator Readability
Are undefined or inconsistently expanded acronyms slowing your FDA/EU reviews and triggering preventable queries? In this lesson, you’ll implement a regulator-calibrated acronym governance system—what to expand, when, how, and where—so every SaMD document reads clearly on first pass. Expect a concise rationale, codified rules, house-style guidance, real-world examples, and targeted exercises to lock in consistency across clinical, software, cybersecurity, and PMS sections. Finish with decision logic and quality gates you can drop into templates, reviews, and automation for measurable cycle-time gains.
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