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Prepared this example Device Risk Management SOP for the purpose of risk analysis training where the pros and cons could be further discussed. This example is modeled on the approach required by ISO 14971 and expands on it with some additional material and possible approaches to consider. Direct use of this SOP is not recommended as it is not suitable for all situations. Training in its proper application as well as additional plans/procedures related to the overall product development lifecycle and to software might be needed to augment this.
SCPRed_SoftwareCPR-RiskManagementSOPTrainingExample1