You can't have any impact at all if you can't legally operate it or if you are hamstrung in your marketing claims.

Chatgpt is just words. This is an ultrasound imaging system. Who knows what could go wrong: blown out eardrums from feedback, acoustic burns, wild inaccuracies that lead to misdiagnosis.

There's really no way around documentation as a way of collecting evidence that the team knows what they are doing. Things like enumerating all the possible patient risks, assessing their severity, updating the design to mitigate, and ultimately testing that it works as intended.

This is why you can't just bolt on the medical device part. Most devs will have a conniption if suddenly expected to attend lots of meetings and do a lot of paperwork. Different skillset and very expensive to switch out your whole workforce.