In a member webinar hosted by techUK, experts from the Medicines and Healthcare products Regulatory Agency (MHRA) provided a comprehensive introduction to the UK’s regulatory framework for software as ...

In medical-device software, an update isn’t just a new feature — it can directly affect patient safety. Every code change in a surgical-laser system must be fully traceable to its verification and ...

Connected medical devices improve patient care but introduce severe cybersecurity risks that require stringent regulatory oversight.

The software supply chain is critical to ensuring a secure medical device that can prevent injury, according to Gregg Van Citters, MS, PhD, a principal software quality engineering consultant at ...

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There has been a surge in academic and business interest in software as a medical device (SaMD). It enables medical professionals to streamline existing medical practices and make innovative medical ...

The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical technologies. This article examines the 2024 guidelines from the U.S. Patent and ...

“Don’t fear the Reaper,” the rock band Blue Öyster Cult famously advised. For many digital health companies, the Food and Drug Administration’s recently revised guidances affecting the classification ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

Generative artificial intelligence powered features such as chatting about what is in pictures, telling children bedtime stories, and imitating podcasters continue to roll out despite fears the ...

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Propel Software, creator of the first product value management (PVM) platform that transforms how businesses create, market, sell, and service products, has ...