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  • williamzembricki replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 7 years, 6 months ago

    One aspect of low severity risk that people need to understand is that no matter what it is going to occur. You try your hardest to avoid these situations with sampling an strong quality establishment but it is never going to be a 100% perfect situation. A product that is failing at a very low rate and is not damaging or hurting patients does not mean that the product needs to be altered or corrected. Those that occur with a high severity are the ones that are going to need the huge actions such as a recall. The companies that do not recall and allow other products from the same lot fail are the companies that wait too long to try fix the issue. A low severity risk that occurs rarely is not something that has to even truly warrant a response. A high severity issue needs a strong and fast response.