In computers, medical software is a significant branch of software engineering. 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. In the European Union, these include the Medical Devices Directive.
In the United States, the Food and Drug Administration has increased its involvement in reviewing the development of medical device software starting in the mid-1980s, where coding errors in a radiation therapy device (Therac-25) resulted in the overdose of patients. FDA is now focused on regulatory oversight on medical device software development process and system-level testing.
In the recent years, IEC 62304 has become the benchmark standard for the development of medical software,
