The "Market Authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Training Course (ONLINE EVENT: March 26-27, 2025)" has been added to ResearchAndMarkets.com's ...

Medical and Healthcare Products Regulatory Agency (MHRA) has released new guidance to help manufacturers meet UK medical ...

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

What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.

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.

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

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

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 ...

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 ...