IEC 62304 – Software Development
Software for medical devices must be developed to IEC 62304, which encompasses the processes and procedures required and establishes a common framework for the medical device software lifecycle process.
The IEC 62304 software standard ensures that software development encompasses requirements capture, risk analysis, architectural and detailed design, code implementation, validation, verification and traceability throughout the entire development process. It also covers the update, configuration and maintenance processes required after software is released in a device.
There is a corresponding standard, IEC 82304, which applies to software that is developed for use on general computing platforms, such as desktop computers and mobile devices.