62304-mapping

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IEC 62304:2006 Mapping of Requirements to Documents

This table maps all requirements of the IEC 62304:2006 (by section) to the relevant documents (here: OpenRegulatory templates).

Note that the document names in the “Fulfilled in Document” column are based on the OpenRegulatory templates. You’ll probably have a different system for assigning document names, so feel free to rename them.

Classes Section Title Fulfilled in Document Comment
(General) 4.1 Quality management system Quality Management Manual
4.2 Risk management SOP Integrated Software Development
4.3 Software Safety Classification Risk Management Report
4.4 Legacy Software (Not applicable) Not applicable unless you have legacy software.
A, B, C 5.1.1 Software development plan Software Development and Maintenance Plan
A, B, C 5.1.2 Keep software development plan update SOP Integrated Software Development
A, B, C 5.1.3 Software development plan reference to system design and development Software Development and Maintenance Plan
C 5.1.4 Software development standards, methods and tool planning Software Development and Maintenance Plan
B, C 5.1.5 Software integration and integration test planning Software Development and Maintenance Plan
A, B, C 5.1.6 Software verification planning Software Development and Maintenance Plan
A, B, C 5.1.7 Software risk management planning Software Development and Maintenance Plan
A, B, C 5.1.8 Documentation planning Software Development and Maintenance Plan
A, B, C 5.1.9 Software configuration management planning Software Development and Maintenance Plan
B, C 5.1.10 Supporting items to be controlled Software Development and Maintenance Plan
B, C 5.1.11 Software configuration item control before verification Software Development and Maintenance Plan
B, C 5.1.12 Identification and avoidance of common software defects Software Development and Maintenance Plan
A, B, C 5.2.1 Define and document software requirements from system requirements SOP Integrated Software Development; Software Requirements List
A, B, C 5.2.2 Software requirements content Software Requirements List
B, C 5.2.3 Include risk control measures in software requirements Software Requirements List
A, B, C 5.2.4 Re-evaluate medical device risk analysis SOP Integrated Software Development
A, B, C 5.2.5 Update requirements SOP Integrated Software Development
A, B, C 5.2.6 Verify software requirements SOP Integrated Software Development; Checklist Software Requirements
B, C 5.3.1 Transform software requirements into an architecture SOP Integrated Software Development; (Software architecture diagrams, interface documentation)
B, C 5.3.2 Develop an architecture for the interfaces of software items SOP Integrated Software Development; (Software architecture diagrams, interface documentation)
B, C 5.3.3 Specify functional and performance requirements of SOUP item SOUP list
B, C 5.3.4 Specify system hardware and software required by SOUP item SOUP list
C 5.3.5 Identify segregation necessary for risk control SOP Integrated Software Development
B, C 5.3.6 Verify software architecture SOP Integrated Software Development; Checklist Software Architecture
B, C 5.4.1 Subdivide software into software units SOP Integrated Software Development; (Software architecture diagrams)
C 5.4.2 Develop detailed design for each software unit SOP Integrated Software Development
C 5.4.3 Develop detailed design for interfaces SOP Integrated Software Development
C 5.4.4 Verify detailed design SOP Integrated Software Development
A, B, C 5.5.1 Implement each software unit SOP Integrated Software Development; (GitHub Pull Requests / GitLab Merge Requests)
B, C 5.5.2 Establish software unit verification process SOP Integrated Software Development
B, C 5.5.3 Software unit acceptance criteria SOP Integrated Software Development
C 5.5.4 Additional software unit acceptance criteria SOP Integrated Software Development
B, C 5.5.5 Software unit verification SOP Integrated Software Development; (CI/CD in GitHub Pull Requests / GitLab Merge Requests)
B, C 5.6.1 Integrate software units SOP Integrated Software Development; (Merge in GitHub / GitLab)
B, C 5.6.2 Verify software integration SOP Integrated Software Development; (Merge in GitHub / GitLab)
B, C 5.6.3 Software integration testing SOP Integrated Software Development; (Merge in GitHub / GitLab, CI/CD)
B, C 5.6.4 Software integration testing content SOP Integrated Software Development; (CI/CD in GitHub Pull Requests / GitLab Merge Requests)
B, C 5.6.5 Evaluate software integration test procedures SOP Integrated Software Development
B, C 5.6.6 Conduct regression tests SOP Integrated Software Development; (CI/CD in GitHub Pull Requests / GitLab Merge Requests)
B, C 5.6.7 Integration test record contents SOP Integrated Software Development; (CI/CD in GitHub Pull Requests / GitLab Merge Requests)
B, C 5.6.8 Use software problem resolution process SOP Software Problem Resolution
A, B, C 5.7.3 Retest after changes SOP Integrated Software Development
A, B, C 5.7.4 Evaluate software system testing SOP Integrated Software Development; Software System Test Plan
A, B, C 5.7.5 Software system test record contents SOP Integrated Software Development; Software System Test Protocol
A, B, C 5.8.1 Ensure software verification is complete SOP Integrated Software Development; Checklist Software Release
A, B, C 5.8.2 Document known residual anomalies SOP Integrated Software Development; (Release notes / changelog)
B, C 5.8.3 Evaluate known residual anomalies Risk table; (Release notes / changelog)
A, B, C 5.8.4 Document released versions SOP Integrated Software Development; (Release notes / changelog)
B, C 5.8.5 Document how released software was created SOP Integrated Software Development; (Release notes / changelog)
B, C 5.8.6 Ensure activities and tasks are complete SOP Integrated Software Development; Checklist Software Release
A, B, C 5.8.7 Archive software SOP Integrated Software Development; (Tagged commit in git)
A, B, C 5.8.8 Assure reliable delivery of released software SOP Integrated Software Development
A, B, C 6.1 Establish software maintenance plan Software Development and Maintenance Plan
A, B, C 6.2.1.1 Monitor feedback
A, B, C 6.2.1.2 Document and evaluate feedback
A, B, C 6.2.1.3 Evaluate problem report’s affects on safety SOP Problem Resolution
A, B, C 6.2.2 Use software problem resolution process SOP Problem Resolution
A, B, C 6.2.3 Analyse change requests SOP Change Management
A, B, C 6.2.4 Change request approval SOP Change Management
A, B, C 6.2.5 Communicate to users and regulators SOP Change Management
A, B, C 6.3.1 Use established process to implement modification SOP Change Management
A, B, C 6.3.2 Re-release modified software system SOP Change Management
B, C 7.1.1 Identify software items that could contribute to a hazardous situation SOP Integrated Software Development
B, C 7.1.2 Identify potential causes of contribution to a hazardous situation SOP Integrated Software Development
B, C 7.1.3 Evaluate published SOUP anomaly lists SOP Integrated Software Development
B, C 7.1.4 Document potential causes SOP Integrated Software Development
B, C 7.2.1 Define risk control measures SOP Integrated Software Development
B, C 7.2.2 Risk control measures implemented in software SOP Integrated Software Development
B, C 7.3.1 Verify risk control measures SOP Integrated Software Development
7.3.2 (Not used)
B, C 7.3.3 Document traceability SOP Integrated Software Development; Software Requirements List
A, B, C 7.4.1 Analyse changes to medical device software with respect to safety SOP Change Management
B, C 7.4.2 Analyse impact of software changes on existing risk control measures SOP Change Management
B, C 7.4.3 Perform risk management activities based on analyses SOP Change Management
A, B, C 8.1.1 Esablish means to identify configuration items Software Development and Maintenance Plan
A, B, C 8.1.2 Identify SOUP SOP Integrated Software Development
A, B, C 8.1.3 Identify system configuration documentation SOP Integrated Software Development
A, B, C 8.2.1 Approve change requests SOP Change Management
A, B, C 8.2.2 Implement changes SOP Change Management
A, B, C 8.2.3 Verify changes SOP Change Management
A, B, C 8.2.4 Provide means for traceability of change SOP Change Management
A, B, C 8.3 Configuration status accounting Software Development and Maintenance Plan
A, B, C 9.1 Prepare problem reports SOP Software Problem Resolution
A, B, C 9.2 Investigate the problem SOP Software Problem Resolution
A, B, C 9.3 Advise relevant parties SOP Software Problem Resolution; SOP Incident Reporting
A, B, C 9.4 Use change control process SOP Change Management
A, B, C 9.5 Maintain records SOP Software Problem Resolution
A, B, C 9.6 Analyse problems for trends SOP Software Problem Resolution
A, B, C 9.7 Verify software problem resolution SOP Software Problem Resolution
A, B, C 9.8 Test documentation contents SOP Integrated Software Development

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