Software Anomalies
Software as a Medical Device (SaMD) requires a unique approach to risk management, bridging ISO 14971 and IEC 62304.
Probability of Software Failure
The most critical concept to grasp is that in IEC 62304, the probability of a software anomaly occurring is always assumed to be 100%. You cannot mitigate a software risk by claiming the code is "unlikely" to fail.
Safety Classification
Instead, mitigation must focus on the architecture. Can a hardware watchdog catch the software failure? Can a segregated software process monitor the critical function?
Your ISO 14971 risk analysis directly determines your IEC 62304 Software Safety Classification (Class A, B, or C). A thorough hazard analysis early in development prevents you from over-classifying your software and facing unnecessary regulatory burdens.