The short answer is no, you cannot use only FMEA and be compliant to ISO 14971.
FMEA focuses only on single fault conditions (see also B5 of the TS 24971) with the scope of improving the reliability/robustness of the system.
ISO14971 focuses on hazards (safety for patient/user) that might result from a sequence of events (so a far more complex situation than only single fault).
FMEA provides valuable input and is an important part of the risk management file (a failure being one of the events within the sequence).
ISO 14971:2019 address patient or user harm (and a few other things). It does this by identifying hazards, sequences of events leading to hazardous situations, leading to harm. Then apply risk reduction measures to reduce the frequency and severity of the harm.An FMEA addresses a different problem, failures, and specifically single point failures.Patient or user harm can occur in either normal of fault conditions. An FMEA doesn't cover harm from normal conditions. In addition, device failures don't always result in harm. Designs should be fail-safe.The only solution is to follow the ISO 14971:2019 process which means analyzing hazards not failures. The good news that you could reuse much of the information from the FMEAs. Also, recognize the usability in 62366-1 is a specific application of ISO 14971:2019, so it follows the same process, but addresses specific sources of risk.
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