> That standard [IEC 62304] is surrounded by other technical reports and guidances recognized by the FDA, on software risk management, safety cases, software validation. And I can tell you that the FDA is very picky, when they review your software design and testing documentation. For the first version and for every design change.
> That’s good news for all of us. An adverse event like the Therac 25 is very unlikely today.
This is a case where regulation is a good thing. Unfortunately I see a trend lately where almost any regulation is seen as something stopping innovation and business growth. There are room for improvements and some areas are over regulated, but we don't want a "DOGE" chainsaw to regulations without knowing what the consequences are.