IEC 62304
International standard for medical device software lifecycle processes.
- Cost
- Paid
- Hardware
- Runs on any laptop
- Scanner
- Not required
- Your data
- Stays on your machine
- Licence
- proprietary
- Maturity
- production
- From
- IEC
What it is
Defines the lifecycle requirements for medical device software: planning, requirements, architecture, verification, release and maintenance, scaled by safety class.
Caveats
Not free. Budget for it if you intend to build a regulated product.
Licence notes
The standard must be purchased from IEC or a national body.
Related
Catalogued 2026-08-02, last checked 2026-08-02. View the source record · Report an error