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Actually IEC62304, which describes Sw development lifecycle for medical devices, was precisely written in answer of the Therac accident. All medical devices wit
by seren 7y ago
Actually IEC62304, which describes Sw development lifecycle for medical devices, was precisely written in answer of the Therac accident. All medical devices with Software you use nowadays has to follow IEC 62304.
It does not mean that medical device SW is perfect or bug-free, but it means that the manufacturer should demonstrate some level of risk management, verification and validation to the regulatory bodies before being allowed to sell a new product. It is not perfect but you should not get sick because someone pushed some untested bug fix on Friday night and you have an exam on Monday morning on an untested SW release, the process would not allow it.
- ska 7y agoThat's not quite right, these things didn't come in with 62304. For a (US based) example, before adopting it the FDA still expected you to demonstrate risk & hazard analysis, V&V, and generally SDLC lifecycle management to your SW products (just like hardware ones). However, they offered no opinion on how you should do it. But the overarching standard you were held to as a manufacturer is (still) ISO13485. And coming from a hardware centric view of things, the FDA wasn't sure how to evaluate SW processes, and different panels did things differently. What IEC62304 adds to the mix is specific guidance on your SDLC process. If I recall correctly you are still not required to audit to in the US but new projects should follow it or demonstrate why they are not.
- seren 7y agoThanks for the historical perspective.