Blog
Updates and thoughts on rigorous AI-assisted engineering for regulated industries.
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The FDA Is Reading Your Release Notes
A warning letter over a retrained model, a refused shortcut for experienced radiology AI makers, and FDA's first framework for generative AI. Twelve weeks of FDA activity on AI-enabled devices point the same way: your change history is now part of your submission.
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Spec First, Agents Second
Why we build software with Spec-Driven Development, and why it matters most when the stakes are regulated.