Regulations for Software as Medical Devices in the US and EU
3 min readMar 1, 2023
In Part 1, we discussed the difference between developing software as medical devices (SaMDs) and traditional software development. SaMDs are subject to strict regulations to ensure their safety and effectiveness, and the development process for these devices is different from traditional software development. In this article, we’ll delve further into the regulations for SaMDs in the…
