Template: IEC 62304:2006 Mapping of Requirements to Documents

Dr. Oliver Eidel
Updated April 26, 2024
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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.

ClassesSectionTitleFulfilled in DocumentComment
(General)4.1Quality management systemQuality Management Manual
4.2Risk managementSOP Integrated Software Development
4.3Software Safety ClassificationRisk Management Report
4.4Legacy Software(Not applicable)Not applicable unless you have legacy software.
A, B, C5.1.1Software development planSoftware Development and Maintenance Plan
A, B, C5.1.2Keep software development plan updateSOP Integrated Software Development
A, B, C5.1.3Software development plan reference to system design and developmentSoftware Development and Maintenance Plan
C5.1.4Software development standards, methods and tool planningSoftware Development and Maintenance Plan
B, C5.1.5Software integration and integration test planningSoftware Development and Maintenance Plan
A, B, C5.1.6Software verification planningSoftware Development and Maintenance Plan
A, B, C5.1.7Software risk management planningSoftware Development and Maintenance Plan
A, B, C5.1.8Documentation planningSoftware Development and Maintenance Plan
A, B, C5.1.9Software configuration management planningSoftware Development and Maintenance Plan
B, C5.1.10Supporting items to be controlledSoftware Development and Maintenance Plan
B, C5.1.11Software configuration item control before verificationSoftware Development and Maintenance Plan
B, C5.1.12Identification and avoidance of common software defectsSoftware Development and Maintenance Plan
A, B, C5.2.1Define and document software requirements from system requirementsSOP Integrated Software Development; Software Requirements List
A, B, C5.2.2Software requirements contentSoftware Requirements List
B, C5.2.3Include risk control measures in software requirementsSoftware Requirements List
A, B, C5.2.4Re-evaluate medical device risk analysisSOP Integrated Software Development
A, B, C5.2.5Update requirementsSOP Integrated Software Development
A, B, C5.2.6Verify software requirementsSOP Integrated Software Development; Checklist Software Requirements
B, C5.3.1Transform software requirements into an architectureSOP Integrated Software Development; (Software architecture diagrams, interface documentation)
B, C5.3.2Develop an architecture for the interfaces of software itemsSOP Integrated Software Development; (Software architecture diagrams, interface documentation)
B, C5.3.3Specify functional and performance requirements of SOUP itemSOUP list
B, C5.3.4Specify system hardware and software required by SOUP itemSOUP list
C5.3.5Identify segregation necessary for risk controlSOP Integrated Software Development
B, C5.3.6Verify software architectureSOP Integrated Software Development; Checklist Software Architecture
B, C5.4.1Subdivide software into software unitsSOP Integrated Software Development; (Software architecture diagrams)
C5.4.2Develop detailed design for each software unitSOP Integrated Software Development
C5.4.3Develop detailed design for interfacesSOP Integrated Software Development
C5.4.4Verify detailed designSOP Integrated Software Development
A, B, C5.5.1Implement each software unitSOP Integrated Software Development; (GitHub Pull Requests / GitLab Merge Requests)
B, C5.5.2Establish software unit verification processSOP Integrated Software Development
B, C5.5.3Software unit acceptance criteriaSOP Integrated Software Development
C5.5.4Additional software unit acceptance criteriaSOP Integrated Software Development
B, C5.5.5Software unit verificationSOP Integrated Software Development; (CI/CD in GitHub Pull Requests / GitLab Merge Requests)
B, C5.6.1Integrate software unitsSOP Integrated Software Development; (Merge in GitHub / GitLab)
B, C5.6.2Verify software integrationSOP Integrated Software Development; (Merge in GitHub / GitLab)
B, C5.6.3Software integration testingSOP Integrated Software Development; (Merge in GitHub / GitLab, CI/CD)
B, C5.6.4Software integration testing contentSOP Integrated Software Development; (CI/CD in GitHub Pull Requests / GitLab Merge Requests)
B, C5.6.5Evaluate software integration test proceduresSOP Integrated Software Development
B, C5.6.6Conduct regression testsSOP Integrated Software Development; (CI/CD in GitHub Pull Requests / GitLab Merge Requests)
B, C5.6.7Integration test record contentsSOP Integrated Software Development; (CI/CD in GitHub Pull Requests / GitLab Merge Requests)
B, C5.6.8Use software problem resolution processSOP Software Problem Resolution
A, B, C5.7.3Retest after changesSOP Integrated Software Development
A, B, C5.7.4Evaluate software system testingSOP Integrated Software Development; Software System Test Plan
A, B, C5.7.5Software system test record contentsSOP Integrated Software Development; Software System Test Protocol
A, B, C5.8.1Ensure software verification is completeSOP Integrated Software Development; Checklist Software Release
A, B, C5.8.2Document known residual anomaliesSOP Integrated Software Development; (Release notes / changelog)
B, C5.8.3Evaluate known residual anomaliesRisk table; (Release notes / changelog)
A, B, C5.8.4Document released versionsSOP Integrated Software Development; (Release notes / changelog)
B, C5.8.5Document how released software was createdSOP Integrated Software Development; (Release notes / changelog)
B, C5.8.6Ensure activities and tasks are completeSOP Integrated Software Development; Checklist Software Release
A, B, C5.8.7Archive softwareSOP Integrated Software Development; (Tagged commit in git)
A, B, C5.8.8Assure reliable delivery of released softwareSOP Integrated Software Development
A, B, C6.1Establish a software maintenance planSoftware Development and Maintenance Plan
A, B, C6.2.1.1Monitor feedback
A, B, C6.2.1.2Document and evaluate feedback
A, B, C6.2.1.3Evaluate problem report’s affects on safetySOP Problem Resolution
A, B, C6.2.2Use software problem resolution processSOP Problem Resolution
A, B, C6.2.3Analyse change requestsSOP Change Management
A, B, C6.2.4Change request approvalSOP Change Management
A, B, C6.2.5Communicate to users and regulatorsSOP Change Management
A, B, C6.3.1Use established process to implement modificationSOP Change Management
A, B, C6.3.2Re-release modified software systemSOP Change Management
B, C7.1.1Identify software items that could contribute to a hazardous situationSOP Integrated Software Development
B, C7.1.2Identify potential causes of contribution to a hazardous situationSOP Integrated Software Development
B, C7.1.3Evaluate published SOUP anomaly listsSOP Integrated Software Development
B, C7.1.4Document potential causesSOP Integrated Software Development
B, C7.2.1Define risk control measuresSOP Integrated Software Development
B, C7.2.2Risk control measures implemented in softwareSOP Integrated Software Development
B, C7.3.1Verify risk control measuresSOP Integrated Software Development
7.3.2(Not used)
B, C7.3.3Document traceabilitySOP Integrated Software Development; Software Requirements List
A, B, C7.4.1Analyse changes to medical device software with respect to safetySOP Change Management
B, C7.4.2Analyse impact of software changes on existing risk control measuresSOP Change Management
B, C7.4.3Perform risk management activities based on analysesSOP Change Management
A, B, C8.1.1Establish means to identify configuration itemsSoftware Development and Maintenance Plan
A, B, C8.1.2Identify SOUPSOP Integrated Software Development
A, B, C8.1.3Identify system configuration documentationSOP Integrated Software Development
A, B, C8.2.1Approve change requestsSOP Change Management
A, B, C8.2.2Implement changesSOP Change Management
A, B, C8.2.3Verify changesSOP Change Management
A, B, C8.2.4Provide means for traceability of changeSOP Change Management
A, B, C8.3Configuration status accountingSoftware Development and Maintenance Plan
A, B, C9.1Prepare problem reportsSOP Software Problem Resolution
A, B, C9.2Investigate the problemSOP Software Problem Resolution
A, B, C9.3Advise relevant partiesSOP Software Problem Resolution; SOP Incident Reporting
A, B, C9.4Use change control processSOP Change Management
A, B, C9.5Maintain recordsSOP Software Problem Resolution
A, B, C9.6Analyse problems for trendsSOP Software Problem Resolution
A, B, C9.7Verify software problem resolutionSOP Software Problem Resolution
A, B, C9.8Test documentation contentsSOP Integrated Software Development

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