Software Engineering is a regulated profession in some cases. Here's one of numerous standards: http://en.wikipedia.org/wiki/IEC_62304 http://en.wikipedia.org

Software Engineering is a regulated profession in some cases. Here's one of numerous standards: http://en.wikipedia.org/wiki/IEC_62304 http://en.wikipedia.org/wiki/IEC_62304 Here's some FDA guidance covering Software Validation in Medical Devices: http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm http://www.fda.gov/medicaldevices/deviceregulationandguidanc... It's absolutely essential that the FDA and international standards be applied when building a medical device, and that means that software must be developed according to the regulations. Here's one reason why: http://en.wikipedia.org/wiki/Therac-25 http://en.wikipedia.org/wiki/Therac-25