In this article, I want to explore an idea that often is framed in moral terms but is actually a cybernetic imperative: the necessity of diversity for viable systems.

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.

The role of quality leaders, and quality itself, is expanding. It includes thinking strategically, solving problems, implementing improvements, and driving change throughout the organization.

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.