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  • hzy2 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 6 years, 4 months ago

    When developing a new product or device, there is always a risk that things might go wrong. In order to effectively deal with and overcome these risks, companies need to come up with risk management plans. Dr. Simon mentioned in this week’s lecture that there are 4 ways in which this can be done: Accepting the risk, avoiding the risk, transferring the risk and mitigating the risk. To answer your question, I would assume avoiding the risk is the way to go when it comes to high severity risks. This means that you would have to completely change the plan you had for your device initially to a plan that doesn’t carry those same risks. For low severity risks, I would think that you would use the mitigation strategy where you work to limit that risk. Accepting the risk and taking no action to correct it is probably the most useless one out of the other 3 strategies.