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Also in medical devices. IIRC FDA has standards for software writing/testing/certification.
by auxym 12y ago
Also in medical devices. IIRC FDA has standards for software writing/testing/certification.
- FLUX-YOU 12y agoI'm not sure how much faith I'd put in that. http://www.wired.com/2014/04/hospital-equipment-vulnerable/ http://www.wired.com/2014/04/hospital-equipment-vulnerable/ http://en.wikipedia.org/wiki/Barnaby_Jack#Insulin_pumps http://en.wikipedia.org/wiki/Barnaby_Jack#Insulin_pumps
- mcmancini 12y agoFDA requirements mostly target the SDLC: risk analysis, change control, documentation, v&v, &c. Companies are afforded a surprising amount of flexibility in implementation. Basically, you must have a documented process that you follow, but you're left to your own devices in creating the process. Deviations from voluntary industry standards (e.g., TIR 45) is permissible since they're not specifically required. The DoD, aerospace, and automotive industries have in comparison far more detailed and strict regulatory requirements.