In computers, medical software is a significant branch of software engineering and many medical devices that monitor or control patients are predominantly controlled by software. Medical devices are frequently regulated and must comply with local and regional laws, including the Medical Devices Directive for devices in the European Union (EU). 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.
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“As we speak of poetical beauty, so ought we to speak of mathematical beauty and medical beauty. But we do not do so; and that reason is that we know well what is the object of mathematics, and that it consists in proofs, and what is the object of medicine, and that it consists in healing. But we do not know in what grace consists, which is the object of poetry.”
—Blaise Pascal (1623–1662)