The international standard IEC 62304 – medical 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 (EU) and the United States (US), 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 (software of unknown pedigree or provenance). 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.
Software development process
- Software development planning
- Software requirements analysis
- Software architectural design
- Software detailed design
- Software unit implementation and verification
- Software integration and integration testing
- Software system testing
- Software release
Effect of safety classification on required development process documentation
|Software documentation||Class A||Class B||Class C|
|Software development planning||X||X||X|
|Software requirements analysis||X||X||X|
|Software architectural design||X||X|
|Software detailed design||X|
|Software unit implementation||X||X||X|
|Software unit verification||X||X|
|Software integration and integration testing||X||X|
|Software system testing||X||X||X|
|X - required|
Software maintenance process
- Establish software maintenance plan
- Problem and modification analysis
- Modification implementation
Software risk management process
- Analysis of software contributing to hazardous situations
- Risk control measures
- Verification of risk control measures
- Risk management of software changes
- Security and reliability through software quality
Software configuration management process
- Configuration identification
- Change control
- Configuration status accounting
Software problem resolution process
- Prepare problem reports
- Investigate the problem
- Advise relevant parties
- Use change control process
- Maintain records
- Analyse problems for trends
- Verify software problem resolution
- Test documentation contents
- International Electrotechnical Commission (IEC)
- List of IEC standards
- IEC 60601
- ISO 14971
- ISO 13485
- ISO 9001
- International Standards for automating the software structural quality
- Time-triggered system (a software architecture that is used in many safety-critical systems)
- International Electrotechnical Commission (2006). "Medical device software – Software life cycle processes" (PDF). INTERNATIONAL IEC STANDARD 62304 First edition 2006-05. International Electrotechnical Commission. Retrieved 2 June 2012.
- "Medical devices - European standards - Enterprise and Industry". 2012-11-04. Retrieved 2018-07-26.
- Staff (20 August 2012). "Recognized Consensus Standards". FDA US Food and Drug Administration. US Department of Health & Human Services. Retrieved 26 January 2015.
- Hall, Ken (June 1, 2010). "Developing Medical Device Software to IEC 62304". EMDT - European Medical Device Technology. Retrieved 2012-12-11.
- "IEC 62304:2006(en) Medical device software — Software life cycle processes". ISO. 2006. Retrieved 15 June 2017.
- "Developing Medical Device Software to IEC 62304 | MDDI Medical Device and Diagnostic Industry News Products and Suppliers". www.mddionline.com. Retrieved 2017-06-15.