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  • gy66 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 6 years, 7 months ago

    In terms of high risk, I would probably lean towards either mitigation or transference, depending on the situation. If the high severity of risk is able to be sufficiently resolved or at least minimized by me and my team, obviously mitigating it directly would be the best course of action. Otherwise, transferring it on to the appropriate teams would be the best course of action. For low severity risk, depending on how low the risk is, acceptance may be the smarter move. Financially speaking, it may not be worth devoting the time and resources into resolving a low risk issue so simply acknowledging and accepting it would be preferable. However, it may be appropriate to impose procedures and record the findings to avoid similar low risk issues in the future (avoidance). Out of the types of risk management, obviously acceptance would be the one option that would not reduce the risk severity at all unless, as mentioned already, steps are taken to avoid similar risks in the future.