IEC 62304 is an international standard that sets minimum requirements for the most important processes of the software life cycle. It applies both to manufacturers who develop their software as an independent medical device (standalone software) and to those who merely embed software in their medical device (embedded software).
Based on DIN EN ISO 14971, the standard also describes the role of risk management within the software development process. Specifically, IEC 62304 defines requirements for the following processes of the software life cycle:
- Software development
- Software maintenance
- Software risk management
- Software Configuration Management
- Software problem solving