About this brief.

AI SaMD Playbook is a working brief on how regulators around the world are governing artificial intelligence in Software as a Medical Device. It is written for RA, QA, security, and product leaders making submission and lifecycle decisions today · not for hypothetical 2030 readers.

• · Every claim links to a primary source · regulator publication, gazette, or official guidance.
• · Each regulator page carries a visible "Last reviewed" date.
• · When guidance changes, we update the page and the date · we do not silently revise.
• · We name our sponsor in every section where commercial interest could be inferred.

AI SaMD Playbook is published with sponsorship from Blue Goat Cyber, a medical device cybersecurity firm with 250+ FDA submissions to its name. Sponsorship funds the editorial work; it does not determine which regulators we cover or how we characterise their guidance.

Found something stale or wrong? Use the contact form on the home page · we publish corrections at the next review.