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I can assure you, as a former quality engineer at a medical device development facility, that there is absolutely, positively zero chance that anyone there will use any AI-powered coding tools to write code that goes onto any device that is ISO-13485, CE, or otherwise compliant to some existing medical device regulations (I speak in the USA and European markets; I cannot speak for other markets). There is literally a defined waterfall development cycle for FDA-regulated devices that requires software features to be very precisely specified, implemented, validated, tested, and manufactured. Anyone suggesting using AI at such a facility would be laughed out of the room, and perhaps even re-trained on the procedures. Anyone caught using such tools would probably be fired immediately and all their code patches would be put under intense scrutiny and possibly even rewritten; of course the device software they were working on would remain in development and not released until that was fixed.



I would offer similar sentiment for aerospace.


The above two comments show the difference between software "engineers" vs "developers"...and none of the major social media platforms (and other consumer-level applications) employ engineers.


Other projects can't use waterfall development because they would like to actually produce something useful instead of what was decided at the start of the project.

This isn't the way pharmaceuticals are developed; we don't require the pharma companies to know how they work (and we shouldn't, because we don't know how many common safe drugs work). We validate them by testing them instead.


Other projects can't use waterfall development because they would like to actually produce something useful instead of what was decided at the start of the project.

It's a whole different world of software development. If you set out to build flight control software because it is needed to run on a new airplane, you're not going to pivot midstream and build something else instead.




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