风险管理流程
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风险管理流程
Adapted from EN ISO 14971 Clause 4.1
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| graph LR subgraph input [Input 输入] rmp["Risk management plan\n风险管理计划"] --> ra["Risk analysis 风险分析"] ra --> re["Risk evaluation\n风险评价"] re --> rc["Risk control\n风险控制"] rc --> eor["Evaluation of residual risk\n剩余风险评估"] eor --> rmr["Risk management review\n风险管理评估"] rmr --> pappa["Production and post-production activities\n生产和生产后活动"] pappa --> rmp pappa <--> ra end subgraph output [Output 输出] rmf["Risk management file\n风险管理档案"] end input --> output
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