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.

Software documentation requirements according to IEC 62304

To learn more about developing software in compliance with IEC 62304 standard, see Simulink for V&V, Polyspace static code analysis products, and IEC Certification Kit.