IEC 62304 defines the software life cycle requirements for medical device systems. The standard applies to all software used in medical devices, including embedded, standalone, and application software. IEC 62304 was developed by the International Electrotechnical Commission (IEC), a leading international standards organization.
The standard is based on an internationally recognized software development process model known as V-model. The V-model is a robust approach that has been proven successful in many industries.
IEC 62304 divides the software development process into four phases: planning, development, validation, and maintenance. Each phase must be completed before proceeding to the next phase.