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  • myton replied to the topic how far is "As Far As Possible" in the forum Risk Analysis for Medical Devices 7 years, 4 months ago

    As the standard states, the company must, to the best of their ability, reduce the risk to the lowest level possible. I believe that this could be done by being able to address all the issues present in the device. After stating the issues, solutions for these issues must be presented in an orderly manner with the possible outcomes also listed. By doing so, it can be said that the device has been completely evaluated and all possible turnout for the device has been checked. To prove that the device has been completely solved, it is important to have risks that are low-level, meaning that these issues will not cause harm or deleterious effects to the user.