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<p>Regulatory agencies are requiring companies to systematically demonstrate software safety in their implantable devices, even those already developed. The authors devised a rigorous software safety analysis technique and applied it to a nearly-completed cardiac rhythm management device. They were able to identify safety faults, modify the software to mitigate them, and verify overall safety.</p>
prosthetics; safety; software reliability; legislation; medical computing; pacemakers; retrofitting; cardiac rhythm management device; implantable medical device; regulatory agencies; rigorous software safety analysis technique; safety faults; software modification; safety verification

L. Elliott, S. Kirani, W. Tsai and R. Mojdehbakhsh, "Retrofitting Software Safety in an Implantable Medical Device," in IEEE Software, vol. 11, no. , pp. 41-50, 1994.
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