IEC 62304:2006/AMD 1:2015,Medical device software — Software life cycle processes — Amendment 1.
IEC 62304 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 standard does not prescribe the name, format, or explicit content of the documentation to be produced. This standard requires documentation of TASKS, but the decision of how to package this documentation is left to the user of the standard.
IEC 62304 identifies two additional PROCESSES considered essential for developing safe MEDICAL DEVICE SOFTWARE. They are the software configuration management PROCESS (Clause8) and the software problem resolution PROCESS (Clause9) .