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  • sns34 replied to the topic how far is "As Far As Possible" in the forum Risk Analysis for Medical Devices 8 years, 4 months ago

    Reducing risks “as far as possible” is definitely a huge challenge for manufactures. I believe that the statement implies that not all of the risks can be reduced 100%, but it should be reduced as much as possible in order for the device to be used safely. In regards to medical device companies, possible risks should never be overlooked, even if there is a chance that the risk may not occur. A medical device is created for a consumer to use effectively and in a safe manner, and thus, safety is undoubtedly the most important aspect. These possible risks should be taken into account by the company’s risk analysis team. In the end, manufactures should be able to verify that the risks have been reduced as much as possible and the product should be deemed as acceptable.