After years of development, the EU’s comprehensive medical device database (EUDAMED) becomes mandatory in phases starting in early 2026.

Medical devices are only as safe and effective as their users’ ability to operate them correctly. Even the most advanced technology can fail if patients or healthcare professionals misunderstand instructions, misuse the device, or encounter confusing interfaces. Regulators now recognize usability and human factors as central to patient safety. In 2025, both FDA and EU regulators are emphasizing patient-centric design, usability validation, and clear labeling. These expectatio

European medical device makers face a key May 26, 2026 deadline under the extended MDR transition timelines.

Medical device companies are no longer judged solely on product safety and regulatory compliance.

On February 2, 2026, the FDA’s Quality Management System Regulation (QMSR) will officially replace the long-standing Quality System Regulation (QSR).

Digital health is no longer a niche within the medical device sector.

In vitro diagnostics (IVDs) form the backbone of modern healthcare, guiding everything from infectious disease management to cancer treatment decisions.

For years, emerging markets were seen as relatively accessible expansion opportunities for medical device manufacturers.

Sterilization is a critical step in the medical device lifecycle. Without it, millions of life-saving devices such as catheters, surgical kits, implants, and diagnostic tools would never reach patients safely.