IEC 60601-1 - Medical Electrical Equipment Safety
Clause 14: programmable electrical medical systems – IEC 60601-1 - Medical Electrical Equipment Safety

IEC 60601-1 - Medical Electrical Equipment Safety 14.3: 14.3 Risk management plan

Besides what 4.2.2 asks of it, the risk management plan also points to the 14.11 PEMS validation plan.

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Other controls in Clause 14: programmable electrical medical systems – IEC 60601-1 - Medical Electrical Equipment Safety

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.