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  • au45 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 8 years, 4 months ago

    For low severity risks you are either going use acceptance or mitigation. You are going to have to determine if the benefit is worth the risk. If the benefit is worth the severity of risk you are taking on you can accept the risk and go on with our product. If the benefit is not significant enough for the risk you are going to have to mitigate severity and determine if the cost it takes to mitigate the product is worth not just avoiding it. For high severity risks you are either going to use transference or avoidance. If there is a high severity of risk but the benefit is too valuable to give up you use transference. This allows an insurance company to take on liability for this risk your product must take. If you find the benefit is not worth taking on such a high severity of risk you are better off just avoiding the risk entirely. Out of the four methods, acceptance does not affect the severity of the risk at all. You would accept when the benefit far outweighs the risk it brings to your product.