Medical device regulation and safety are critical components of healthcare, ensuring that devices used in medical settings are safe and effective for patient use. Recent research has highlighted ...

For those with Class IIa or above AI-related devices, compliance with the EU’s AI Act is likely to be akin to the EU MDR.

Recent developments – at national and international levels – in the regulation and governance of data, AI and medical devices are having significant impacts and potential impacts on the application of ...

New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain ...

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...

It's not clear what the new medical device regulations for bringing products to market in the UK will be, but manufacturers will have more time before such regulations are rolled out. The Medicines ...

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 ...

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: ...

and help inform an ongoing process to update regulations on guidance covering medical devices, software as a medical device (SaaMD), and AIaMD, according to Campbell. While the programme predates ...