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 6.3.2: 6.3.2 Re-release modified software system

Modifications are released according to 5.8, as a full re-release or as a modification kit of changed items with the tools to install them. Applies to classes A, B and C.

Maintained by Gerard BlokdykControl text last updated 21 May 2026

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

6.1 6.1 Establish software maintenance plan
6.2.1 6.2.1 Document and evaluate feedback
6.2.2 6.2.2 Use software problem resolution process
6.2.3 6.2.3 Analyse change requests
6.2.4 6.2.4 Change request approval
6.2.5 6.2.5 Communicate to users and regulators
6.3.1 6.3.1 Use established process to implement modification

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The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpoint All IEC 62304:2015 Medical Device Software Lifecycle Processes controls