This standard was last reviewed and confirmed in 2021. Therefore this version remains current.
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.
Status: PublishedPublication date: 2006-05
Edition: 1Number of pages: 151
Technical Committee: ISO/TC 210 Quality management and corresponding general aspects for medical devices
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|std 1 330||Paper|
|std 2 330|