In the medical device industry, compliance isn’t a pop quiz. The U.S. Food and Drug Administration (FDA) has given you all the answers to the test in the form of a regulation: 21 CFR Part 820. That doesn’t mean it’s easy to ace the test.

Wrapped snugly in a custom container, seven carefully chosen materials left Earth on Aug. 24, 2025, traveling at 17,500 mph.

Capability maturity model integration (CMMI) is a process improvement framework required by many U.S. government contracts. If you’ve been through a CMMI appraisal in aerospace or federal contracting, you know there’s a typical pattern. Things look great on paper.

Let’s be honest. Conformity assessment has become dangerously comfortable. It’s familiar, structured, and predictable.

Integrating environmental, health, and safety (EHS) with quality management is no longer optional for manufacturers; it’s essential for achieving operational excellence, ensuring ISO compliance, and driving sustainable growth.

Data are the backbone of our digital world. From healthcare to finance, and from government agencies to private businesses, organizations everywhere rely on vast amounts of data to function effectively.

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.

In recent months, through several of my professional activities, a recurring and increasingly concerning pattern has emerged: The use of AI to generate client responses to accreditation assessment findings (nonconformities) as well as participant essays, exercises, a

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

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