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FDA: Software Failure Behind 24% Of Medical Device Recalls

chicksdaddy (814965) writes | more than 2 years ago

Government 0

chicksdaddy writes "Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the U.S. Food and Drug Administration's (FDA's) Office of Science and Engineering Laboratories (OSEL).
The absence of solid architecture and "principled engineering practices" in software development affects a wide range of medical devices, with potentially life-threatening consequences, the FDA warned. In response, FDA told Threatpost that it is developing tools to disassemble and test medical device software and locate security problems and weak design."

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