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  • kbs27 replied to the topic Discussion Topic: Risk Management, Risk Analysis in the forum Risk Analysis for Medical Devices 8 years, 4 months ago

    Risk management is the process of combining a risk assessment with decisions on how to address that risk, and doing so in ways that consider the technical and social aspects of the risk assessment. Risk management is part of a larger decision process that considers the technical and social aspects of the risk situation. Risk assessments are performed primarily for the purpose of providing information and insight to those who make decisions about how that risk should be managed. Judgment and values enter into risk assessment in the context of what techniques one should use to objectively describe and evaluate risk. Judgment and values enter into risk management in the context of what is the most effective and socially acceptable solution.