Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

To protect both the user and patient, medical device developers must pay strict attention to the safety of a device's software. Risk-mitigated software design is crucial. Timothy Cuff and Steven ...

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 ...

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...

The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...

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 ...

The latest update to the Federal Drug Administration (FDA) for medical device cybersecurity mandates the development of a software bill of materials (SBOM). This provision can be a significant ...

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 ...

“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 ...