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Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes.
| Author | ISO/TC 210 Quality management and corresponding general aspects for medical devices |
|---|---|
| Editor | ISO |
| Document type | Standard |
| Format | Paper |
| Edition | 1 |
| Number of pages | 151 |
| Modified by | IEC 62304:2006/Amd 1:2015 |
| Weight(kg.) | 0.3567 |
| Year | 2006 |
| Country | Switzerland |