Articles By Eric Larson
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You Can't CAPA What You Can't Classify
9/16/2026
An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.
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The People Who Turn An Idea Into A Deliverable Product
9/15/2026
Drug developers and device engineers share more common ground than their distinct disciplines suggest, facing parallel pressures around design, safety, regulatory approval, and scalable performance.
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09.15.26 -- Spanish Is Not One Regulatory Language
9/15/2026
09/15/26 Med Device Online Newsletter
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Who Exactly Owns Quality?
9/15/2026
We’ve all heard the rhetorical question, “Who owns quality?” And we all reply with the answer they expect to hear: “We all do!” This mindset needs to be fully integrated into the minds and systems of a company.
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8 Regulations Every Biotech & Pharma Quality Leader Must Know
9/14/2026
Navigate essential biotech and pharma regulations safely. Learn how unifying global standards streamlines audits and accelerates development schedules.
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The Life Sciences Guide To AI In Quality & Compliance
9/14/2026
Implement AI in quality workflows without regulatory risk. Learn how strong governance and clear validation keep you audit-ready for compliance.
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09.14.26 -- Precision Is Only The Beginning: Driving Better Device Outcomes
9/14/2026
09/14/26 Med Device Online Newsletter
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Navigating The New Era Of Design Controls For SaMDs: A Strategic Guide
9/13/2026
[UNSCHEDULED]
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Chile's Easy Market Ends In 2028
9/11/2026
For years, Chile has been a comparatively easy to enter market for the medtech industry. That era now has an expiration date. High-risk, technically complex products will be the most affected by a new decree.
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Engineering Medical Devices To Improve Oral Delivery Of Biopharmaceuticals
9/10/2026
Two approved GLP-1 pills validated the demand — and exposed the ceiling that only delivery devices can break.