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 6.3.1: 6.3.1 Use established process to implement modification

A modification is carried out by working out which clause 5 activities must be redone because of it and then doing them, with the risk management of software changes handled under 7.4. 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
6.3.2 6.3.2 Re-release modified software system

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