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jnm22 started the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 8 years, 5 months ago
As I was going through the lecture I realized a lot of risk management is done before the product hits the market or done on the company side. This made me think of labels and instructions for use. I read somewhere that instructions for use and labels are deemed as the least effective way to solve residual risk, which is the risk left over after a company has done all it can to ensure safety. I have always understood this as a part of risk control and was surprised that it is actually considered the least effective. For something such as painkillers the manufacturers can only do so much to protect the patient and it is ultimately up to the patient to be responsible. Do you think this is fair for companies? What else can a company do to to ensure proper use by the customer for their own saftey. Or what can they do about residual risk?