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nda4 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
I like how you pointed out the importance of avoidance in high severity scenarios. It is also important to know in terms of cost, risk acceptance does not reduce any effects however it is still considered a strategy. This strategy is a common option when the cost of other risk management options such as avoidance or limitation may outweigh the cost of the risk itself. A company that doesn’t want to spend a lot of money on avoiding risks that do not have a high possibility of occurring will use the risk acceptance strategy. Risk avoidance is the opposite of risk acceptance. It is the action that avoids any exposure to the risk whatsoever. Risk avoidance is usually the most expensive of all risk mitigation options. In terms of company size and budget, I wonder if cost would play a factor in the steps of their risk assessment strategy.