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jad73 replied to the topic how far is "As Far As Possible" in the forum Risk Analysis for Medical Devices 7 years, 4 months ago
This phrase does pose a difficult situation because gauging “As Far As Possible” is pretty much relative. However, I think that thorough assessment of risks involved ,whether it be severe or minor, and providing solutions to either avoid or mitigate these risks is best. This would also tie into another discussion topic regarding risk management documentation being considered a living document; where constantly updating this document can help eliminate risks involved with the product.