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