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ajm73 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 7 years, 2 months ago
At the end of the day, it seems that there will always be residual risk that a medical device company will have to deal with. The measures that companies take will not be guaranteed to completely eliminate risk. In fact, even if companies provide warning labels, seminars, trainings, what have you, there will always be the possibility that a user will use a product in the incorrect way, causing harm. An article I found explains a bit of this in terms of how residual risk is managed.
Residual risk is dealt in the following ways (according to the article:
avoid it
reduce it
accept it
transfer itOne example that stuck out to me in terms of managing residual risk is transferring it to another entity. For health companies risk is often deffered to insurance companies.