US FDA Quality Systems regulations contains requirements that add up to Risk Management.
Design Validation - “Shall include software validation and Risk analysis, where appropriate…” (21 CFR 820.309(g))
The preamble to the final rule of the Quality System Regulations state that "Manufacturers shall identify possible hazards associated with the design in both normal and fault conditions. If any risk is judged unacceptable, it should be reduced to acceptable levels...".
The Q9 - Quality Risk Management can be considered for Medical Devices too. You can take look in the References section and there are couple of ISO and non ISO documents listed.
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