Medical software plays an important role in modern health care. A significant branch of software engineering in its own right, medical software is a form of embedded software, used in medical devices.
A wide variety of medical devices incorporate embedded software. Some of these, such as X-ray scanners, heart rate, blood pressure and breathing monitors, are used for analyzing patients. Others, such as medication pumps, are used to treat patients.
In both cases, people's health and safety depend on the medical software deployed being reliable, safe and bug-free.
To this end, the International Electrotechnical Commission developed the IEC 62304 standard. The standard, formulated to govern the requirements for medical software, describes the specifications that medical software must meet in order to be approved for use in medical devices.
The standard is harmonized between the United States and the European Union, so that a system that complies with its regulatory requirements can be used in both markets.
When creating medical software, developers often utilize rigorous embedded software testing tools to ensure that their product meets the requirements of IEC 62304.