Determine your software safety class under IEC 62304 in five minutes
Our interactive tool for Software as a Medical Device (SaMD) and embedded software as part of a medical device. A first assessment in 5 minutes.
Does your software fall under safety class A, B or C of IEC 62304? This classification decides how much effort you have to put into development, verification and maintenance of your software medical device. You will find more on the topic in our guide.
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The decision tree of IEC 62304 and the explanations sit side by side. On a phone display the diagram becomes so small that the wording of the standard is no longer legible.
Please open this page on a desktop computer or on a tablet in landscape orientation.
The decision tree from Figure 3 of IEC 62304 is loading.
Official diagram from IEC 62304:2006+AMD1:2015 (Figure 3)
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