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Featured

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The New Standard for Medtech QMS
Elizabeth Weddle
The quality systems most medtech teams are stuck with aren’t built for how they work today. 21 CFR Part 820 was authorized by the Federal Food, Drug, and Cosmetic Act of 1978, long before the software industry even existed. And while the regulations themselves aren’t going anywhere, the world they were built for has changed dramatically. The medical device industry came late to the software…

Lean

Understanding the Nuances of Humanlike Intelligence

What can we learn about human intelligence by studying how machines “think?” Can we better understand ourselves if we better understand the artificial intelligence systems that are becoming a more significant part of our everyday lives?

These questions may be deeply philosophical…

The Hidden Cost of a Fragmented QMS in Life Sciences

Implementing a new quality management system (QMS) is no small task, especially for life science companies faced with stringent regulatory requirements and a high validation burden. Entrenched legacy systems compound the problem as organizational inertia and complacency lead companies to make do…

The Quality Profession: A Noble Calling

I’ve been in and around the quality profession for decades. When I first started, we were most concerned about products failing in our customers’ hands... too often and too soon. I worked at General Motors in those days, in the Frigidaire division when Frigidaire was part of General Motors. We…

Stop Bleeding $260,000 per Hour

Your facility has detailed standard operating procedures (SOPs), ISO certifications, and quality management systems that would impress any auditor. But operators still skip calibration checks when production is behind, modify machine settings without authorization during shift changes, and…

Real-World Lessons on Laser Marking

The global coding- and marking-equipment market is on a clear growth path. As shown in a recent Grand View Research report, the market was worth $17,528 million worldwide by the end of 2024.

Furthermore, GVR’s projections estimate the market value will reach $24,927 million by…

The ABCs of Modern Manufacturing

To stay profitable as a manufacturer, you have to run a tight ship. I’ve been lucky enough to visit with owners and key people at thousands of manufacturers all over the world. My main goal during these visits is to listen and learn what makes them so good at what they do.

It…

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21st Annual Northeast Lean Conference
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Women of FABTECH
Program continues to gain momentum in 2025
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Bridging the gap between 2D-inspection quality requirements planning and 3D metrology
Datanomix Expands AI Capabilities to Help Manufacturers
AI designed to fit directly into production, allowing manufacturers to act faster and smarter within lean teams
ETQ Boosts Data Access Capabilities of ETQ Reliance NXG
Enables customers to securely access quality data when and where they need it
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