Standards · Standard or regulation
IEC 62304
Medical device software, Software life cycle processes
In plain words
What it covers.
The standard for how medical device software is planned, written, tested, released and maintained. Software is put into safety class A, B or C depending on the harm it could contribute to, and higher classes need more rigorous processes such as detailed design and unit verification. It also covers problem resolution and changes after release.
Who uses it: Software engineers and manufacturers of devices with software or software as a medical device.
A summary written by BMEssentia for learning, not the text of the standard. Always work from the current official edition and the manufacturer's instructions.
It covers
- Software safety classification A, B and C
- Software development planning
- Requirements, architecture and detailed design
- Unit, integration and system testing
- Software of unknown provenance (SOUP)
- Maintenance and problem resolution
- Configuration and change management
Key points
What engineers need to know.
- Class A: no injury possible; Class B: non-serious injury possible; Class C: death or serious injury possible.
- Third-party code (SOUP) must be listed and its risks assessed.
- Every change after release follows the same controlled process, including firmware updates.
- Traceability links requirements to code and to tests.
- Known anomalies must be evaluated before release.
- Cybersecurity work links to IEC 81001-5-1 and to the risk file.
Devices
Devices it applies to.
Each device in the Medical City Device Lab, with its Device Library course on the Platform.
Medical City
Where you practise it.
- Design Studio verification stage
- S1-M043 software change control
- S3-M046 missed monitor software update