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

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

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

In 2025, there’s been a marked increase in FDA warning letters. During the second quarter of 2025 alone, the U.S. Food and Drug Administration (FDA) issued 172 warning letters.

Here’s something nobody saw coming: The generation most skeptical of AI isn’t the one that doesn’t understand it. It’s the one that understands it best.

In the evenings, after patients have left for the day, our research team visits the radiation oncology offices at the University of Colorado Anschutz Medical Campus to talk to medical physicists about how our research can help cancer patients.

At the corner of quality and assembly, design engineers are frequently confronted with unexpected, complex fluid process issues in the prototyping phase.

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.

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.