Retrofitting software safety in an implantable medical device |
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Authors: | Mojdehrakhsh R Wei-Tek Tsai Kirani S Elliott L |
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Affiliation: | Cardiac Pacemakers Inc., St. Paul, MN; |
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Abstract: | 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 |
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