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IEC 62304
IEC 62304
The IEC 62304 is an internationally harmonized standard for medical device software lifecycle processes, recognized by FDA and other regulatory agencies across the world.
IEC 62304 provides guidance to the manufacturer on planning, development, and postmarket surveillance activities for medical device software to ensure companies are in compliance with both U.S. and other international regulatory requirements.
The standard IEC 62304 applies when the software stands alone as a medical device (commonly referred to as software as a medical device, or SaMD), is a component of a medical device, or is used in the production of a medical device.