CROSSWALK
IEC 62304 Software Lifecycle Crosswalk
Clause-by-clause breakdown of IEC 62304 software lifecycle process requirements. See how each clause maps to ISO 13485 design controls and what the scanner checks.
Software Lifecycle
| IEC 62304 Clause | ISO 13485 Mapping | Requirement | Gaps | Details |
|---|---|---|---|---|
| §4.3 | 7.3.2 | Software Safety Classification | 3 | View → |
| §5.1 | 7.3.2 | Software Development Planning | 2 | View → |
| §5.2 | 7.3.3 | Software Requirements Analysis | 2 | View → |
| §5.3 | 7.3.4 | Software Architectural Design | 3 | View → |
| §5.5 | 7.3.5 | Software unit implementation | 2 | View → |
| §5.7 | 7.3.6 | Software System Testing | 3 | View → |
| §5.8 | 7.3.8 | Software Release | 1 | View → |
| §6 | 8.5.2 | Software Maintenance | 2 | View → |
| §7 | 7.3.3 | Software Risk Management | 1 | View → |
| §8 | 4.2.3 / 4.2.4 / 7.5.3 | Software Configuration Management | 2 | View → |
| §9 | 8.5.2 | Software Problem Resolution | 1 | View → |
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