Medical Device Software Safety Classification

How to classify your medical device software per IEC 62304?
Not all software is equal.
IEC 62304 defines 3 software safety classes based on risk of harm resulting from a hazardous situation.
Here’s a quick reminder:
Class A: The software doesn’t lead to a hazardous situation. Or, if it does, the risk is low enough to be considered acceptable (after applying external RCM).
Class B: The software might cause a hazardous situation. But the most it would lead to is a non-serious injury.
Class C: The same situation could result in serious injury or death. Even when external risk control measures are applied.
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