IEC 62304 Software Lifecycle Crosswalk
Each IEC 62304 software lifecycle clause, mapped to its ISO 13485 design-control counterpart — safety classification, planning, and verification, with the scanner's checkpoints called out.
Group by:
Change Control
| IEC 62304 Clause | ISO 13485 Mapping | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| §8 | 4.2.3 / 4.2.4 / 7.5.3 | Software Configuration Management | View → |
Design & Development
| IEC 62304 Clause | ISO 13485 Mapping | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| §4.3 | 7.3.2 | Software Safety Classification | View → | |
| §5.1 | 7.3.2 | Software Development Planning | View → | |
| §5.2 | 7.3.3 | Software Requirements Analysis | View → | |
| §5.3 | 7.3.4 | Software Architectural Design | View → | |
| §5.5 | 7.3.6 | Software unit implementation | View → | |
| §5.7 | 7.3.6 | Software System Testing | View → | |
| §5.8 | 7.3.8 | Software Release | View → | |
| §7 | 7.3.3 | Software Risk Management | View → | |
| §4.4.2 | Legacy Software Risk Management Activities | View → | ||
| §4.4.3 | Legacy Software Gap Analysis | View → | ||
| §4.4.4 | Legacy Software Gap Closure Activities | View → | ||
| §4.4.5 | Legacy Software Rationale for Continued Use | View → | ||
| §5.4.1 | 7.3.4 | Subdivide Software into Software Units | View → | |
| §5.4.2 | 7.3.4 | Develop Detailed Design for Each Software Unit | View → | |
| §5.4.3 | 7.3.4 | Develop Detailed Design for Software Unit Interfaces | View → | |
| §5.4.4 | 7.3.6 | Verify Software Detailed Design | View → | |
| §5.6.1 | 7.3.4 | Integrate Software Units | View → | |
| §5.6.2 | 7.3.6 | Verify Software Integration | View → | |
| §5.6.3 | 7.3.6 | Software Integration Testing | View → | |
| §5.6.4 | 7.3.6 | Software Integration Testing Content | View → | |
| §5.6.5 | 7.3.6 | Evaluate Software Integration Test Procedures | View → | |
| §5.6.6 | 7.3.6 | Conduct Regression Tests During Integration | View → | |
| §5.6.7 | 7.3.6 | Integration Test Record Contents | View → |
Measurement, Analysis & Improvement
| IEC 62304 Clause | ISO 13485 Mapping | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| §9 | 8.5.2 | Software Problem Resolution | View → |
Production & Service Provision
| IEC 62304 Clause | ISO 13485 Mapping | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| §6 | 7.3.9, 8.5.2 | Software Maintenance | View → |
Other standards
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