IEC 62304


The international standard IEC 62304medical device software – software life cycle processes is a standard which specifies life cycle requirements for the development of medical software and software within medical devices. It is harmonized by the European Union and the United States, and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.

Implications of IEC 62304 for software

The IEC 62304 standard calls out certain cautions on using software, particularly SOUP. The standard spells out a risk-based decision model on when the use of SOUP is acceptable, and defines testing requirements for SOUP to support a rationale on why such software should be used.

Contents

General requirements

Software maintenance process