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 14.4: 14.4 PEMS development life - cycle

A PEMS development life cycle is documented with a set of defined milestones, each defining the activities to complete and the verification methods for them, each activity defined with its inputs and outputs, each milestone naming the risk management work to be finished before it is reached, tailored to the specific development through plans detailing activities, milestones and schedules, and including documentation requirements.

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