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One Less Risk

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Increasingly, inspectors for the U.S. Food and Drug Administration (FDA) will evaluate your CMMS provider’s security controls—not just your internal procedures.

Safeguarding Trust and Quality in the Global Marketplace

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The digitalization of society during the last decade has created many opportunities for businesses and organizations.

5 Changes Manufacturers Are Making Today and for Tomorrow

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The manufacturing industry is undergoing a transformation driven by rapid technological advancements, changing consumer preferences, and evolving regulatory frameworks.

Maximize Your Runway

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Early-stage medtech companies are under tremendous pressure to develop quickly, prove value, and obtain regulatory approval or clearance as fast as possible.

Lean Is Not an Acronym

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When I first became involved in lean (continuous improvement), I was the VP of operations at a privately held company in the Midwest.

On Self-Deception in Systems Thinking

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“Do you not know that there comes a midnight hour when everyone has to throw off his mask?”—Søren Kierkegaard

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In this article I want to spend time with Søren Kierkegaard. I’ve been interested in his ideas because he occupies an unusual place in the history of thought. He’s considered a pioneer of existentialism, and yet he was also a man of faith.

Quality and Regulatory Affairs in Medtech

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As we look ahead to 2026, the medtech sector stands at an intersection of regulatory evolution, technological advancement, and operational transformation.

Why Your AI Policy Gap Is a Legal Time Bomb

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Your IT team enabled Copilot and Gemini last quarter without checking with the lawyers. Now your employees are putting company secrets into systems that nobody owns, nobody governs, and nobody can reliably retrieve when opposing counsel sends a subpoena.

Why AI Agents Aren’t Replacing Remote Workers Anytime Soon

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The demos look slick, the promises even slicker. In slides and keynotes, agentic assistants plan, click, and ship your work while you sip coffee.

When Performance Flatlines

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Performance rarely collapses with fanfare. More often, it flatlines quietly; sales soften, productivity slows, priorities blur, and yet teams run hard without moving the needle.

Pagination

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