After my last post, one thing became clear: There’s a lot of confusion around whether AI is “allowed” in regulated environments. Let’s be clear: AI itself isn’t the issue. The issue is how it’s implemented. In FDA-regulated systems, expectations haven’t changed: Systems must be validatedOutputs must be traceableBehavior must be controlled and predictable That’s where…
AI is no longer something “coming soon.”It’s already being embedded into the systems you use every day. ERP platforms. Quality systems. Document management tools.Vendors are rapidly adding AI features to stay competitive. And here’s the problem: Most software vendors do not understand FDA regulatory requirements. The Risk No One Is Talking About I’m seeing more…
Last week, I spoke with a CEO who shared that his company was budgeting to hire fifteen engineers next year to support projected growth. It’s an ambitious and exciting plan — but also a costly one. For many medtech startups and small businesses, that level of headcount expansion can represent millions in overhead before a…
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