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 ...

Artificial intelligence-enabled medical devices with no clinical validation were more likely to be the subject of recalls, according to a study published in JAMA Health Forum. The study, published on ...

To simplify and enhance medical device connectivity across health systems, Oracle Health has launched the Oracle Health Device Validation Program for the U.S.—establishing a standardized approach to ...

April 01, 2026 - PRESSADVANTAGE - As clinical research, pharmaceutical development, and medical device innovation ...

The FDA's new Quality Management System Regulation doesn't just align American standards with global practice—it fundamentally redefines what regulators mean by 'quality.' Medical device companies ...

We’ve all heard process validation horror stories. Validations can take years. Creeping elegance can take over. Product launches can be stopped in their tracks. When implemented correctly, however, ...

AI is transforming health care, but a new study from researchers at Johns Hopkins, Georgetown, and Yale suggests we might be moving too fast to integrate the technology into clinical settings. Their ...