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.

If you’ve flown in the U.S. in recent years, you’re probably familiar with the airport security experience of entering a booth, raising your hands above your head, and having a machine check your body. That machine is called a millimeter wave scanner.

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

Early-stage medtech companies are under tremendous pressure to develop quickly, prove value, and obtain regulatory approval or clearance as fast as possible.

In today’s digital age, the question isn’t whether you’ll experience a cybersecurity attack, but when this might occur. Cybercriminals strike when you least expect it, with devastating consequences for your day-to-day operations.

In manufacturing, failure isn’t an option—it’s a liability. A defective part or a missed delivery triggers a chain reaction that can disrupt schedules, undermine trust, and drain resources.

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.

Even the smallest manufacturer would never consider using a typewriter to develop an invoice, or manage a sales prospect list from a Rolodex.