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So I finally got curious and took a look. I found this document useless from a regulatory perspective, because, unless I missed something, it doesn't identify the harms associated with the risks.
Oh good, my second opportunity to rant about this today. IMO, anyone really qualified to make this determination would tell you that trying to quantify the severity associated with a clinical harm makes no clinical sense whatsoever In this case, it's just plain weird, because you don't even know what harms are being rated. It's like, well, if some kind of harm occurred, then whatever kind of harm it might be, it would have a severity of 2.
Don't tease me, Seymour! Have you ever actually known an ISO 13485 auditor to cite this as a finding?
Engineering associates are typically not qualified to make a determination as what types of injury require professional medical intervention.
Oh good, my second opportunity to rant about this today. IMO, anyone really qualified to make this determination would tell you that trying to quantify the severity associated with a clinical harm makes no clinical sense whatsoever In this case, it's just plain weird, because you don't even know what harms are being rated. It's like, well, if some kind of harm occurred, then whatever kind of harm it might be, it would have a severity of 2.
(Feel free to view this as a potential audit finding against 13485 - Human Resources)
Don't tease me, Seymour! Have you ever actually known an ISO 13485 auditor to cite this as a finding?