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  • au45 replied to the topic how far is "As Far As Possible" in the forum Risk Analysis for Medical Devices 8 years, 4 months ago

    At times it is very unlikely to be able to eliminate all risk in a medical device. The article posted above does a great job explaining what “as far as possible” implies in the IPO. This just ensures that the cost to reduce the risk has absolutely no influence whether the risk is considered acceptable or not. Without this companies would try and get past with mitigating the risks to a point that is only financially beneficial for the company. This ensures the safety of the patient is a high priority than the financial revenue of the product. If you are able to prove that there are no other possible methods to mitigate the risk this would be considered reducing the risk as far as possible.