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. Applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device. This standard does not cover validation and final release of the med...
[PDF.rl85] IEC 62304 Ed. 1.0 b:2006, Medical device software - Software life cycle processes Rating: 4.64 (485 Votes)
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