Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...

In large part, this has meant navigating the requirements of the European Union’s Medical Device Regulation (EU MDR). Introduced in 2017, the MDR mandates sweeping regulatory reforms that are ...

Consumers Union, the advocacy arm of Consumer Reports, agrees with the Institute of Medicine that the current system of medical-device regulation doesn't protect patients from harm. Consumers ...

STAT covers the development, regulation and use of medical devices. Topics include the safety of medical devices, the challenges of bringing new devices to market and the role of medical devices ...

As AI in the medical device space rises, it likely means 2025 will be another challenging year for cyber threats in healthcare.

The EU MDR certification is recognized globally for ensuring that medical devices meet stringent requirements ... and compliance with the highest regulatory standards. Signifier is a pioneer ...

The challenges in meeting regulatory requirements during a clinical ... panel during the Outsourcing Clinical Trials (OCT) Medical Devices 2025 conference, taking place in Munich, Germany, on ...