Standards

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.

I’ve done this many times and…

Increasingly, inspectors for the U.S. Food and Drug Administration (FDA) will evaluate your CMMS provider’s security controls—not just your internal procedures. In a cloud-hosted GxP environment, data doesn’t stop at your firewall; your vendor’s security posture becomes part of your compliance…

Early-stage medtech companies are under tremendous pressure to develop quickly, prove value, and obtain regulatory approval or clearance as fast as possible. The pace of innovation in the industry has increased tremendously, thanks to more options for outsourcing and new technology like 3D…

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. If your organization is lucky, it can block the attacker and limit…

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.

So when someone suggests a strategy with the word fail in it, skepticism is understandable…

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. A notable enforcement surge occurred in September 2025 when the FDA released 80 warning letters in a single week.…