how to architect ai agents for regulatory approval?

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Summary

Explores how to architect AI agents for regulated industries like SaMD class II, balancing non-deterministic agent usefulness with deterministic safety zones to satisfy regulatory compliance.

spent a lot of time on agent architecture for mission critical environments. getting an agent to browse the web or draft an email is trivial compared to deploying one where a hallucination carries real legal or physical consequences. the problem - in regulated industries, specifically SaMD class II, non-deterministic agents are a compliance nightmare. if the agent's reasoning path changes every time you run the same prompt, you can't validate it for safety, and regulators won't touch it. how do you keep an agentic workflow inside a deterministic safety zone without gutting what makes it useful?
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