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# About this brief.

What this is

_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.

Editorial standards

-   · 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.

Sponsor disclosure

_AI SaMD Playbook_ is published with sponsorship from [Blue Goat Cyber](https://bluegoatcyber.com/), 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.

Corrections

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

© 2026 AI SaMD Playbook · Sponsored by Blue Goat Cyber

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Editorial reference only. Not legal or regulatory advice.