throwaway0261

5 ms·

1. 1.▲
   by throwaway0261 1y ago

   One of the comments said this: > 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 v
2. 2.▲
   by throwaway0261 1y ago

   There was a news story from Norway last year where a car allegedly accelerated by itself, causing the car to fall off the second floor of a parking garage and kill the driver.
3. 3.▲
   by throwaway0261 1y ago

   One of the benefits of regulations in these areas, is that they require proper tests and documentation. This often requires more than one person to handle the load. We don't want to go back to the 80s YOLO mode just because we need to
4. 4.▲
   by throwaway0261 1y ago

   > but i dont think people designing medical devices will be going yolo mode on their dev cycle anytime soon I don't have the same faith in corporate leadership as you, at least not when they see potentially huge savings by firing so