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  • jk299 replied to the topic how far is "As Far As Possible" in the forum Risk Analysis for Medical Devices 8 years, 6 months ago

    I agree, essentially it is this, that a company should do what it reasonability can to ensure all risks are assessed and ensure no negligence is done on the part of the company to put the users at risk. And this should be done without the thought for cost as a mandatory step and due process that regulations and companies owe to the public. It is also to show there is no risk relative to the specifications of the products that go untested.