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  • fo3 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 8 years, 4 months ago

    I agree – There comes a point where the company has done their part by putting warnings on labels and the customer who is using the device is responsible for following those instructions. For that to happen, it is expected that the user is trained to the proper handling and use prior to using it during surgery, for example. As many have said, mistakes do happen, but a lot of mistakes can be attributed to negligence by not reading these labels or IFUs.