3 ms·
Yes. And they are required by the FDA: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085281.htm http://www.fda.gov/Medica
by daveguy 10y ago
Yes. And they are required by the FDA:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085281.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...
Therac-25 is an example of what can happen when medical devices are not held to a high standard:
https://en.wikipedia.org/wiki/Therac-25 https://en.wikipedia.org/wiki/Therac-25
- Waterluvian 10y agoI feel like "engineer overconfidence" is actually laziness. Any time I've felt inclined to say it's fine, wasn't overconfidence. It was laziness to go through the whole process of re-validating something. This seems like an embarrassing admission, but it was part of me learning how to be a programmer. The rookie me wanted to cut corners.
- jschwartzi 10y agoThat document is guidance. In it they suggest static analysis and formal methods, but they do not require them. You might get asked questions during a 510k if you don't explicitly call them out, though. Therac-25 is actually an example of how a bad risk analysis and lack of appropriate mitigations for the level of concern can lead to patient injury or death. The design of the device meant that a single-fault condition in software could create a hazardous situation for the patient. When they revised the design for software control they removed a hardware mitigation.