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 4.4.3: 4.4.3 Gap analysis

Based on the legacy software's safety class, the manufacturer performs a gap analysis of the available deliverables against those clauses 5.2, 5.3, 5.7 and 7 require, assesses the continuing validity of what exists, evaluates for each gap the risk reduction from producing the missing deliverable and its activities, and determines which deliverables to create, the minimum being the software system test records of 5.7.5.

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