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rd389 replied to the topic Factors Contributing to Risk Values in the forum Risk Analysis for Medical Devices 7 years, 5 months ago
Factors contributing the risk index numbers can be divided into three different group:
A. Overall context such as scientific unknowns, varying susceptibility to risk, positive feedback, and loss of safety margins.
B. Human factors such as social dynamics, conflicts of interest and values.
C. Decision maker: Amount of communication, and malicious attacks.