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>I sure as hell didn’t become a developer so I could get thrown in jail for buggy code... You'd better stay away from any company that requires FDA approval. B

>I sure as hell didn’t become a developer so I could get thrown in jail for buggy code... You'd better stay away from any company that requires FDA approval. Believe it or not, every change is signed. By you. By the FDA compliance person. Etc etc. I'll give you two guesses as to how they decide who goes to prison if God forbid something in the software is shown to have caused a fatality? Or, worse, a series of fatalities? That sort of regulation happens even in the software industry. It just depends on the purpose of the software.

mruts 8y ago
That’s really funny actually, I used to work as a developer for the FDA for their researchers. But since we were just publishing meaningless papers, I was probably safe.
yesenadam 8y ago
>I'll give you two guesses as to how they decide who goes to prison if God forbid something in the software is shown to have caused a fatality? Would you mind just telling us instead? Thanks.
- rleigh 8y ago
  See IEC 62304:2006 (https://www.iso.org/standard/38421.html https://www.iso.org/standard/38421.html) and the related standards which govern the formal processes which medical device software must meet for FDA and CE approval (as well as other national standards). The whole process from requirements, specifications, high and low level design, implementation, validation and verification and the rest of the lifecycle requires stringent oversight, including documentation and signoffs. The signatures on those documents have legal meaning and accountability for the engineers who did the analysis and review at each stage.
  - roel_v 8y ago
    Look at this from an economics perspective, do people in this sort of positions get paid more than comparable positions in other fields? I'd never heard of legal liability for software engineers. Has anyone ever been convicted or otherwise been held accountable when there was a failure?
AnimalMuppet 8y ago
I don't think developers get thrown in jail, even for a bug that kills multiple people. The one time I've heard of people getting thrown in jail it was upper management, for trying to game the FDA audit and approval process. They got led out the door in handcuffs by US Marshalls. Source: Worked in FDA-regulated software for six years, at two different places.

mruts 8y ago

That’s really funny actually, I used to work as a developer for the FDA for their researchers. But since we were just publishing meaningless papers, I was probably safe.

yesenadam 8y ago

>I'll give you two guesses as to how they decide who goes to prison if God forbid something in the software is shown to have caused a fatality? Would you mind just telling us instead? Thanks.

rleigh 8y ago
See IEC 62304:2006 (https://www.iso.org/standard/38421.html https://www.iso.org/standard/38421.html) and the related standards which govern the formal processes which medical device software must meet for FDA and CE approval (as well as other national standards). The whole process from requirements, specifications, high and low level design, implementation, validation and verification and the rest of the lifecycle requires stringent oversight, including documentation and signoffs. The signatures on those documents have legal meaning and accountability for the engineers who did the analysis and review at each stage.
- roel_v 8y ago
  Look at this from an economics perspective, do people in this sort of positions get paid more than comparable positions in other fields? I'd never heard of legal liability for software engineers. Has anyone ever been convicted or otherwise been held accountable when there was a failure?

AnimalMuppet 8y ago

I don't think developers get thrown in jail, even for a bug that kills multiple people. The one time I've heard of people getting thrown in jail it was upper management, for trying to game the FDA audit and approval process. They got led out the door in handcuffs by US Marshalls. Source: Worked in FDA-regulated software for six years, at two different places.