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.

The "Medical Device Regulatory Affairs Market Size, Share & Trends Analysis Report By Type, By Service Provider, By Service, ...

When conducting a clinical investigation, meeting regulatory requirements is predicated on factors such as the quality of ...

Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need ...

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The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: ...

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 ...

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 ...

Brad Jolly, Senior Applications Engineer, Keysight Technologies stresses that the alarming increase in ransomware attacks ...