IEC 62304:2006
Medical device software — Software life cycle processes
Standard for the development and maintenance of medical software
- Category
- Harmonised standards
- Market
- European Union
- Applicable classes
- Class I medical device, Class IIa medical device, Class IIb medical device, Class III medical device
In practice
Mandatory for devices with embedded or standalone software. Software safety classes A, B and C. Covers planning, requirements, architecture, testing and maintenance.
Official sources
https://www.iso.org/standard/38421.htmlSee where this text lands in your roadmap
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