Maintaining a skilled team from the bottom up is essential.

When you go to a medical appointment, does the doctor look at you while you talk? Or are they busy typing everything you say into a computer? If it’s the latter, you may find that will change soon, thanks to artificial intelligence.

Measurement, in its most basic form, is about comparing the thing you want to measure with a reference. To measure the length of a table, you compare it to a tape measure. To measure flour for a birthday cake, you compare it to a measuring cup.

During a June 2025 webinar on pragmatic AI applications in healthcare quality management and regulatory affairs, live polling of quality and regulatory professionals revealed that approximately 80% of respondents were actively implementing AI solutions or seriously c

During the last couple of decades working in quality, I’ve lost count of how many times I’ve seen the same pattern play out: A strong launch. Tight focus. Great early results. People doing the right things for the right reasons. Controls are followed.

The medical device industry is counting down to an important deadline: On Feb. 2, 2026, the U.S.

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.