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To: reed13

Having developed software for 20+ years, I can definitively state that “adding features” costs money short and long term. Software is never having to say “we’re done.” There is always maintenance. It’s never once and done. The data must be interpeted and presented to the patient in an understandable format. Then there are storage retention concerns and the management of those records.


12 posted on 02/10/2012 6:00:57 AM PST by BuckeyeTexan (Man is not free unless government is limited. ~Ronald Reagan)
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To: BuckeyeTexan

well aware of both the part 11 software issues/regs with the FDA and the engineers who can’t say “when”, but I’ve worked manufacturing, quality, and New products with lots of change management (including software) and while there is always “room for improvement” there are plenty of release revisions/version cutoffs since it has to get to market some time - and updates are already in the plan for the version already out when it is released the first time...

One of the ‘great’ things of regulated industries is that you are never done as continual improvement is actually required and lack of resources is not an acceptable excuse, though risk assessment/categorization is. In this case it would not be a mandated update due to risk, but a feature upgrade/nice to have that could be incorporated in the next scheduled upgrade/mandatory safety upate.


14 posted on 02/10/2012 7:15:33 AM PST by reed13
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