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Risked Thinking in ISO 13485:2016Risk Management / Analysis of RiskRiskbased thinking in ISO 13485:20161Risk Management Every version of the ISO 13485 standard has advocated risk management and risk
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How risk management is refers to the processes and methods employed to identify, assess, and mitigate risks that could negatively impact an organization or project.
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The information that must be reported includes identified risks, assessment of the likelihood and impact of those risks, mitigation strategies, and any incidents related to risk management.
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