IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 4: general requirements (quality system, risk management, safety classification, legacy software) – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 4.4.5: 4.4.5 Rationale for use of legacy software

The manufacturer records which version of the legacy software is in use and why it is justified to keep using it, drawing on the results of the legacy assessment; that justification is what allows its continued use under the standard.

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