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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Intro Every week, new companies appear promising “secure AI environments” that will keep your data safer than mainstream tools like ChatGPT or Claude.It sounds reassuring — especially for regulated industries — but it’s often a marketing myth. In most cases, these private AI environments don’t actually make your data more secure. They simply add another interface (and another vendor)…
Why Contract Manufacturers Are Losing the Shield of OEM Oversight Under the New CFR/13485 Alignment Intro:The FDA’s alignment of 21 CFR Part 820 with ISO 13485:2016 doesn’t just modernize language — it reshapes accountability across the entire supply chain.For the first time, contract manufacturers and critical suppliers face expanded visibility as OEMs are now required to list, monitor, and trend supplier…
Why Suppliers Are the New Compliance Hotspot Under 13485 and CFR 820 Alignment Intro: The FDA’s planned alignment of 21 CFR Part 820 with ISO 13485:2016 is driving a renewed focus on supplier management.As regulators harmonize U.S. and international frameworks, supplier controls are becoming one of the highest-risk — and highest-priority — elements in QMS evaluations. Key Points: Closing: The…
Remote Audits Are Here to Stay — and They’re Changing the Compliance Playbook Intro: Remote audits, once a pandemic workaround, have become a recognized inspection pathway under FDA and international regulatory programs.While still supplemented by on-site visits, digital and hybrid audits are now a core element of regulatory oversight — and companies must adapt their readiness strategies…
Intro: The FDA’s new ELSA (Enhanced Lifecycle Safety and Accountability) framework signals a major shift in how regulated manufacturers will manage compliance in the years ahead.ELSA moves away from reactive inspection models toward continuous, data-driven oversight — built on digital traceability, remote review, and AI-assisted risk monitoring. Key Points: Closing: ELSA represents the next step in FDA’s vision for predictive,…
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