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  • julienneviuya replied to the topic how far is "As Far As Possible" in the forum Risk Analysis for Medical Devices 8 years, 2 months ago

    I think in the context of any other field, As Far As Possible is daunting and almost unattainable. However, in medical devices and anything else regulated by the FDA, it is necessary. The goal of the FDA is to have products that are safe and effective. It is sensible that companies should not even consider economics when reducing or even completely eliminating risk. To prove this, a company would need to show proof that every foreseeable risk was addressed.