Opinion: Medical device companies can create a competitive advantage by leveraging data to strengthen compliance programs and by ensuring effective oversight of quality and regulatory reporting ...

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 ...

But as these products proliferate, manufacturers face a new set of questions. How do expectations around comfort, usability, ...

Legacy medical devices face growing scrutiny as regulators push for stronger cybersecurity, transparency and risk management.

Oracle Health has introduced a new three-tier validation framework for medical devices that it says standardizes approaches to validating connectivity, functionality and workflow alignment and will ...

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 ...

Dublin, Feb. 25, 2026 (GLOBE NEWSWIRE) -- The "Process Validation for Medical Devices Training Course (June 4th - June 5th, 2026)" training has been added to ResearchAndMarkets.com's offering. This ...

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 ...

Oracle Health has launched a device validation program aimed at standardizing how medical devices connect to health systems and electronic health records. The company introduced the Oracle Health ...