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medical software
The terms medical software and medical device software are undefined terms that can designate any software, software item or system used within a medical context (e.g. medical devices that monitor or control patients are predominantly controlled by software), depending on its intended use / indication for use.
==Overview==
"Medical devices", as a broader term, refers to regulated products that must comply with local and regional laws. In the United States (US), as of the mid-1980s, the Food and Drug Administration (FDA) has increased its involvement in reviewing the development of medical device software, due to patient overdoses caused by coding errors in a radiation therapy device (Therac-25). The FDA is now focused on regulatory oversight in the medical device software development process and system-level testing. Between 1995 and 2005, IEC 62304 became the benchmark standard for the development of medical software in both the EU and the US.
Due to the broad scope covered by these terms, manifold classifications can be proposed for various medical software, based for instance on their technical nature (embedded in a device or standalone), on their level of safety (from the most trivial to the most safety-critical ones), or on their primarily function (treatment, education, diagnostics, data management).
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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