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 ...

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations ...

When things are working fine, it's easy to assume that software updates are unnecessary. But almost every device around you ...

This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision ...

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 ...

“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 ...

Value stream management involves people in the organization to examine workflows and other processes to ensure they are deriving the maximum value from their efforts while eliminating waste — of ...

Xiaomi offers one of the most generous software update policies among Android brands, often supporting its devices longer than many competitors do. But no matter how strong the update promise is, ...

Deploying software to large fleets of Linux-based devices is a complex and critical process that requires careful planning and automated execution. Start with these best practices. The internet of ...