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manolo replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 6 years, 6 months ago
Labels are an essential part of risk management, but I agree that they are the least useful. This is because (from my experience) people do not normally read the warning labels. Think about things that you use on a daily basis, how many of the labels do you actually read before you use the product? The bulk of the risk management has to go into making the product “fool proof” so that you put as little risk as possible in the hands of the user. Is it an inconvenience to go through the trouble of making a label that is barely read? Yes. Yet if you don’t have that label, a user that is harmed would just state that there was not a label on the product to say I was not supposed to use it in a way that was probably supposed to be “common sense.”