When building safety critical software it is very important to build into the steps of your development process a way to show compliance to the relevant standards. For an industry like medical devices this could mean meeting a standard like IEC 62304 which talks about software traceability through everything you build. In order to have everything lined up for easier approval it is important to have data like FMEA (Fault Mode and Effects Analysis) charts. The issue is how do you fully analyze fault modes with the complexity of cascading faults... [More]

Etiquetas:  complaince electronics regulation medical fda multicore rational iec62304 virtualization ibm product smarter fema