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by vardump
4362 days ago
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Like others have told, any complaint you make must be processed by the company. If it endangers human safety, failure to do so is against FDA's rules and can have dire and expensive consequences to the company in question. Fixing bugs in a medical device is not slow because it'd take a long time to fix the bug itself. It's slow because there's a lot of paperwork (Device History Files, specifications, tons of reviews, etc.) and system testing that follows. That's why you'd only correct issues that do not endanger patient safety once there are enough or when they can be combined with new features in firmware. There's also always a risk that those fixed issues cause patient endangering bugs. It can take almost one year from implementing the fix until it is running on any significant number of medical (imaging) devices in question. FDA's rules are there for a reason. Although... someone should tell FDA git exists. It's silly to revision things manually in Word documents. |
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