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

    This is a great question! For high level risks, I would try my best to go with avoidance, I do not want to put the patient and the company at risk, given that we know the failure occurs frequently and its effects are severe. It’s not worth it to put a product out there, that could and most probably will fails and will affect the patient’s health, trust in us, it would affect our partners and clients, our brand name, and so much more. So avoidance is the way to go. For the low level risks, we have some options. If it were a big company with a lot of money, I would go for the transference route. Usually companies don’t sell only one product and have only 3-4 risks to evaluate, they probably have hundreds of products, each with 20-50 risks to evaluate. So the low levels I would try to push off onto someone else’s shoulders so I can focus on the more risky features that would have a larger impact. Transference doesn’t really reduce the risk level, because we don’t really take any actions to amend our product to eliminate the risk but sometimes it’s the most economical route to take.