IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 6: software maintenance process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 6.2.5: 6.2.5 Communicate to users and regulators

Approved change requests that touch released software products are identified, and, as local regulation requires, users and regulators are told about any problem in the released software, what could happen if it keeps being used without change, what changes are available, and how to get and install them. Applies to classes A, B and C.

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