Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...

Ransomware attacks on the healthcare sector surged by 30 percent in 2025, frequently disrupting operational technology and medical devices. FDA Section 524B mandates that manufacturers provide a ...

Chinese-made medical devices pose an imminent threat, warn the FDA, CISA and the American Hospital Association. The federal government's cyber watchdog recently discovered a “backdoor” that can easily ...