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  • sin3 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 6 years, 4 months ago

    I think that it is fair. I do not think there is anything more a company can do to prevent an overdose for example after all the risks have en avoided or mitigated. On many pain killer bottles, there are multiple warnings on the amount that can be ingested before it can become hazardous to one’s health. Once it is on the market, the consumer has full control over the product. God forbid anything happen, unless there was a defect in the product, all risks taken are taken by the consumer as the company has taken all the risks prior to development and evaluated them carefully before releasing it.