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MS IEC 62304:2009
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES (IEC 62304:2006, IDT)
This Malaysian Standard 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. This Malaysian Standard 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.
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NSC R - Medical Devices and Facilities for Healthcare
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