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

    Often times, it is best to determine what the worst case scenario is when making a decision. When making a decision for the safety margins in a medical device, one way to think of what ought to be considered “as far as possible” is to determine what a reasonable investigator (or jury!) would consider being as such when determining whether a medical device company has engaged in malpractice. For example, when a particular risk is defined to be high/low chance or high/low danger, there should be documentation showing why. And if a risk that was not discovered, there must be adequate proof that effort was undertaken to find probable risks, and to show that the specific danger could not reasonably have been found.

    There are of course numerous examples and precedents that can be used to further clarify and define what “as far as possible means.” However, assuming and preparing for the worst is the best option to avoid future difficulties.