IEC 62304, EN 62304…Confused?

 By Nikhil Chauhan

The requirements of IEC 62304 and EN 62304 are identical.  Both, IEC 62304 and EN 62304, share the same genealogy and are well recognized software life cycle standards. The only difference is that they are promoted by two different standardization bodies. IEC (International Electrotechnical Commission) and CENELEC adopted the same standard concurrently.

IEC 62304 is a worldwide recognized standard from IEC that 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.

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