IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 5.1.9: 5.1.9 Software configuration management planning

The plan contains, or points to, the information for software configuration management: which classes, types or categories of item (or which listed items) are controlled; the configuration management activities and tasks; which organizations are responsible and how they relate to development and maintenance; at what point items fall under configuration control; and at what point the problem resolution process is applied. Applies to classes A, B and C.

Maintained by Gerard BlokdykControl text last updated

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Other controls in Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes

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