IEC 62304:2015 Medical Device Software Lifecycle Processes 5.8.2: 5.8.2 Document known residual anomalies

What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes

• 5.1.1 5.1.1 Software development plan
• 5.1.10 5.1.10 Supporting items to be controlled
• 5.1.11 5.1.11 Software configuration item control before verification
• 5.1.12 5.1.12 Identification and avoidance of common software defects
• 5.1.2 5.1.2 Keep software development plan updated
• 5.1.3 5.1.3 Software development plan reference to system design and development
• 5.1.4 5.1.4 Software development standards, methods and tools planning
• 5.1.5 5.1.5 Software integration and integration testing planning