What Is IEC 62304?
IEC 62304 is an international standard published by the International Electrotechnical Commission (IEC) that defines the requirements of the software life-cycle processes for medical device software development. The standard is harmonized by the European Union and the United States and can be used as a reference to comply with the medical device regulations in both markets.
The IEC 62304 standard specifies a set of processes, activities, and tasks that establish a common framework for designing safe and tested software for medical devices. The standard categorizes software into three safety classes according to the consequences to the patient from a possible software failure:
- Class A: No injury or damage to health is possible
- Class B: Non-serious injury is possible
- Class C: Death or serious injury is possible
You can develop IEC 62304-compliant embedded software for medical devices with MATLAB® and Simulink® using Model-Based Design. Model-Based Design is a software development method that incorporates verification and validation into the workflow. This ensures that the software is comprehensively tested and verified before integrating it into a medical device. In addition, parts of the documentation required by IEC 62304 are automatically generated for regulatory compliance. Most Simulink tools used in Model-Based Design have been TÜV SÜV certified for IEC 62304 compliant development workflow.