Insights
Not AI news. Not vendor hype. Practical perspectives from working inside complex, compliance-driven workflows every day.
The FDA just drew clearer lines around AI in medical devices. For mid-market operators, this isn't a compliance headache — it's a forcing function that separates serious AI programs from expensive experiments.
The FDA's 2025 draft guidance on AI-enabled devices buried a major compliance shift inside a document that doesn't even say 'human factors' in the title. Here's what it actually means for your validation strategy.
FDA and EU regulators are locking in AI oversight frameworks for 2026. Most mid-market medical device companies aren't close to ready — and the gap isn't technical, it's operational.
FDA easing oversight on lower-risk AI devices sounds like good news. For mid-market manufacturers, it's actually a trap if you haven't built the right internal scaffolding first.
Most financial services firms are building AI governance programs that look good on paper and collapse under operational weight. Here's what actually works.
New posts go out when they're ready — no filler, no cadence for cadence's sake.
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