In 2021, container ships idled for weeks outside the Port of Los Angeles, a stark visual reminder of just how fragile modern supply-chain reliability had become. The backlog sent shockwaves across industries.

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.

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?

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.

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.

Your facility has detailed standard operating procedures (SOPs), ISO certifications, and quality management systems that would impress any auditor.

The global coding- and marking-equipment market is on a clear growth path.

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.

I’ve worked in manufacturing procurement for just over 25 years. In that time, I’ve learned one thing above all else—precision is the backbone of quality. Every product we make, every part we produce, and every component we measure relies on measuring tool accuracy.

Meritocracy—the idea that individuals should advance based on their talent and hard work—appeals to our sense of fairness. However, despite its noble intentions, meritocracy often fails in practice.