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Issue 06/2015

Standard for medical device software

Consolidated IEC 62304 issued, available as Redline version

Software is often an integral part of medical device technology and trends point to its growing importance in it. A consolidated version of IEC 62304, Medical device software– Software life cycle processes, has just been published. This International Standard provides a framework of life cycle processes with activities and tasks necessary for the safe design and maintenance of medical device software.