Predetermined change-control plans for AI/ML SaMD — how to make them audit-proof

<h1> Introduction¶ </h1> <p>Artificial intelligence now shapes access to credit, housing, employment, healthcare, and justice. In each of these domains, the decisions an algorithm

<p>An auditor sits across from you with a single page of questions. They are not interested in your model architecture, your prompt engineering, or your evaluation harness. They

<p>To be fair, "we have a QMS" is the easiest checkbox in a notified‑body audit. The hard part is that regulators, auditors and — most importantly — frontline engineers do not

<p>A tidy Design History File (DHF) isn't an audit prop; it's the single-document story of how your device became safe enough to put on the market. I say this as someone who has

<p>A few weeks back I gave a coding agent one instruction: <em>"fix the failing import and ship it."</em></p> <p>CI went green. The agent, which I'd allowed to self-merge when

<h2> The Asymmetry of Change: Why Your Tests Are Looking the Wrong Way </h2> <p>A passing build is often treated as a certificate of correctness. In reality, it's a narrow

<p><em>Troy Anthony Cronin is the founder of GuardianChain, LLC and the architect of GC-1 — non-custodial cryptographic evidence infrastructure for AI accountability. 64,000+

<h2> The Hidden Tax on Every MCP Request </h2> <p>Here is something nobody talks about when they demo MCP integrations: token costs at scale.</p> <p>I have been running MCP setups