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 6.2.3: 6.2.3 Analyse change requests

In addition to the clause 9 analysis, each change request is analysed for its effect on the organization, on released software products, and on the systems it interfaces with. 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
6.2.4 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
6.3.2 6.3.2 Re-release modified software system

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