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The path to designing and developing ludicrously expensive medical device software is easier than you might think. In fact, it’s so […]
Verification and validation (V&V) are vital in medical device software development regardless of where you’re looking to sell your device. But […]
Documenting compliance with IEC 62304 in medical device software appears on the surface a vast, monumental task. A monolith that towers […]
SOUP stands for software of unknown provenance, and it repeatedly features throughout the IEC 62304 software lifecycle standard. Whether you do […]
IEC 62304 is a software lifecycle standard that covers the safe design and maintenance of medical device software. It has several […]
How long could a Class III medical device with Class C software take to get FDA approval? For Class III with […]