IEC 62304:2006 Amd 1:2015

Reference Software Lifecycle Process Class

Fullfilled in Document
B

PRIMARY LIFECYCLE PROCESESS

4 General Requirements
4.1 Quality Management Systems X Quality Management Manual
4.2 Risk Management X SOP Integrated Software Development
4.3 Software safety classification * X Risk Management Report
4.4 Legacy Software * X N/A
5 Software development process
5.1 Software development planning
5.1.1 Software Development Plan X Software Development and Maintenance Plan
5.1.2 Software Development Plan maintenance X SOP Integrated Software Development
5.1.3 Software development plan reference to system design and development X Software Development and Maintenance Plan
5.1.4 Software development standard, methods and tools planning Software Development and Maintenance Plan
5.1.5 Software integration and integration testing planning X Software Development and Maintenance Plan
5.1.6 Software verification planning X Software Development and Maintenance Plan
5.1.7 Software risk management planning X Software Development and Maintenance Plan
5.1.8 Documentation planning X Software Development and Maintenance Plan
5.1.9 Software configuration management planning X Software Development and Maintenance Plan
5.1.10 Supporting Items to be controlled X Software Development and Maintenance Plan
5.1.11 Software configuration item controlled before verification X Software Development and Maintenance Plan
5.1.12 Identification and avoidance of common software defects * X Software Development and Maintenance Plan
5.2 Software requirements analysis X
5.2.1 Define and document software requirements from system requirements SOPXIntegrated Software Development; Software Requirements List
5.2.2 Software requirements content X Software Requirements List
5.2.3 Include risk control measures in software requirements X Software Requirements List
5.2.4 Re-evaluate medical device risk analysis X SOP Integrated Software Development
5.2.5 Update requirements X SOP Integrated Software Development
5.2.6 Verify software requirements task SOP Integrated
X Software Development; Checklist Software Requirements
5.3 Software architectural design
5.3.1 Transform software requirements into an architecture SOP Integrated Software
X Development; (Software architecture diagrams, interface documentation)
5.3.2 Develop an architecture for the interfaces of software items SOP Integrated Software
X Development; (Software architecture diagrams, interface documentation)
5.3.3 Specify functional and performance requirements of SOUP item X SOUP list
5.3.4 Specify system hardware and software required by SOUP item X SOUP list
5.3.5 Identify segregation necessary for risk control SOP Integrated Software Development
5.3.6 Verify software architecture SOP Integrated
X Software Development; Checklist Software Architecture
5.4 Software detailed design
5.4.1 Subdivide software into software units SOP Integrated
X Software Development; (Software architecture diagrams)
5.4.2 Develop detailed design for each software unit SOP Integrated Software Development
5.4.3 Develop detailed design for interfaces SOP Integrated Software Development
5.4.4 Verify detailed design task SOP Integrated Software Development
5.5 Software unit implementation
5.5.1 Implement each software unit SOP IntegratedXSoftware Development; (GitHub Pull Requests / GitLab Merge Requests)
5.5.2 Establish software unit verification process X SOP Integrated Software Development
5.5.3 Software unit acceptance criteria X SOP Integrated Software Development
5.5.4 Additional software unit acceptance criteria SOP Integrated Software Development
5.5.5 Software unit verification SOP Integrated Software
X Development;l (CI/CD in GitHub Pull Requests / GitLab Merge Requests)
5.6 Software Integration and Integration Testing
5.6.1 Integrate software units SOPX Integrated Software Development; (Merge in GitHub / GitLab)
5.6.2 Verify software integration SOPX Integrated Software Development; (Merge in GitHub / GitLab)
5.6.3 Software integration testing SOP Integrated
X Software Development; (Merge in GitHub / GitLab, CI/CD)
5.6.4 Software integration testing content SOP Integrated Software
X Development; (CI/CD in GitHub Pull Requests / GitLab Merge Requests)
5.6.5 Evaluate software integration test procedures X SOP Integrated Software Development
5.6.6 Conduct regression tests SOP Integrated Software
X Development; (CI/CD in GitHub Pull Requests / GitLab Merge Requests)
5.6.7 Integration test record contents SOP Integrated Software
X Development; (CI/CD in GitHub Pull Requests / GitLab Merge Requests)
5.6.8 Use software problem resolution process X SOP Software Problem Resolution
5.7 Software system testing
5.7.1 Establish tests for software requirements * X
5.7.2 Use software problem resolution process * X
5.7.3 Retest after changes * X SOP Integrated Software Development
5.7.4 Evaluate software system testing * SOPXIntegrated Software Development; Software System Test Plan
5.7.5 Software system test record contents * SOP Integrated
X Software Development; Software System Test Protocol
5.8 Software release for utilization at a system level
5.8.1 Ensure software verification is complete * SOPXIntegrated Software Development; Checklist Software Release
5.8.2 Document known residual anomalies * SOPXIntegrated Software Development; (Release notes / changelog)
5.8.3 Evaluate known residual anomalies X Risk table; (Release notes / changelog)
5.8.4 Document released versions SOPXIntegrated Software Development; (Release notes / changelog)
5.8.5 Document how released software was created SOPXIntegrated Software Development; (Release notes / changelog)
5.8.6 Ensure activities and tasks are complete SOPXIntegrated Software Development; Checklist Software Release
5.8.7 Archive software * SOP
X Integrated Software Development; (Tagged commit in git)
5.8.8 Assure reliable delivery of released software * X SOP Integrated Software Development
6 Software maintenance process
6.1 Establish software maintenance plan X Software Development and Maintenance Plan
6.2 Problem and Modification
 6.2.1 Document and evaluate feedback
6.2.1.1 Monitor feedback X
6.2.1.2 Document and evaluate feedback X
6.2.1.3 Evaluate problem report's affects on safety X
6.2.2 Use software problem resolution process X
6.2.3 Analyze change requests * X SOP Change Management
6.2.4 Change request approval X SOP Change Management
6.2.5 Communicate to users and regulators X SOP Change Management
6.3 Modification Implementation
6.3.1 Use established process to implement modification X SOP Change Management
6.3.2 Re-release modified software system X SOP Change Management
SUPPORTING PROCESSES
7 Software risk management process
7.1 Analysis of software contributing to hazardous situations
7.1.1 Identify software items that could contribute to a hazardous situation X SOP Integrated Software Development
7.1.2 Identify potential causes of contribution to a hazardous situation X SOP Integrated Software Development
7.1.3 Review published SOUP anomaly lists X SOP Integrated Software Development
7.1.4 Document potential causes X SOP Integrated Software Development
7.1.5 Document sequences of events *
7.2 Risk control measures
7.2.1 Define Risk control measures X SOP Integrated Software Development
7.2.2 Risk control measures implemented in software X SOP Integrated Software Development
7.3 Verification of Risk control measures
7.3.1 Verify Risk control measures X SOP Integrated Software Development
7.3.2 Document any new sequences of events *
7.3.3 Document traceability SOPXIntegrated Software Development;Software Requirements List
7.4 Risk management of software changes
7.4.1 Analyze changes to medical device software with respect to safety X SOP Change Management
7.4.2 Analyze impact software changes on existing risk control measures X SOP Change Management
7.4.3 Perform risk management activities based on analyses X SOP Change Management
8 Software configuration management Process
8.1 Configuration identification
8.1.1 Establish means to identify configuration items X Software Development and Maintenance Plan
8.1.2 Identify SOUP X SOP Integrated Software Development
8.1.3 Identify system configuration documentation X SOP Integrated Software Development
8.2 Change control
8.2.1 Approve Change requests X SOP Change Management
8.2.2 Implement changes X SOP Change Management
8.2.3 Verify changes X SOP Change Management
8.2.4 Provide means for traceability of change X SOP Change Management
8.3 Configuration status accounting Software Development and Maintenance Plan
8.3.1 Configuration status accounting task X
9 Software problem resolution Process
9.1 Prepare problem reports X SOP Software Problem Resolution
9.2 Investigate the problem X SOP Software Problem Resolution
9.3 Advise relevant parties S
XOP Software Problem Resolution; SOP Incident Reporting
9.4 Use change control process X SOP Change Management
9.5 Maintain records X SOP Software Problem Resolution
9.6 Analyze problems for trends X SOP Software Problem Resolution
9.7 Verify software problem resolution X SOP Software Problem Resolution
9.8 Test documentation contents X SOP Integrated Software Development
ents

e documentation)
e documentation)
ams)

e Requests)

Merge Requests)

/CD)
Merge Requests)

Merge Requests)
Merge Requests)
 IEC 62304:2006 Amd 1:2015
Applicable for
Reference Software Lifecycle Process Class Class Class
A B C
PRIMARY LIFECYCLE PROCESESS
4 General Requirements
4.1 Quality Management Systems X X X
4.2 Risk Management X X X
4.3 Software safety classification * X X X
4.4 Legacy Software * X X X
5 Software development process
5.1 Software development planning
5.1.1 Software Development Plan X X X
5.1.2 Software Development Plan maintenance X X X
5.1.3 Software development plan reference to system design and development X X X
5.1.4 Software development standard, methods and tools planning X
5.1.5 Software integration and integration testing planning X X
5.1.6 Software verification planning X X X
5.1.7 Software risk management planning X X X
5.1.8 Documentation planning X X X
5.1.9 Software configuration management planning X X X
5.1.10 Supporting Items to be controlled X X
5.1.11 Software configuration item controlled before verification X X
5.1.12 Identification and avoidance of common software defects * X X
5.2 Software requirements analysis X X
5.2.1 Define and document software requirements from system requirements X X X
5.2.2 Software requirements content X X X
5.2.3 Include risk control measures in software requirements X X
5.2.4 Re-evaluate medical device risk analysis X X X
5.2.5 Update requirements X X X
5.2.6 Verify software requirements task X X X
5.3 Software architectural design
5.3.1 Transform software requirements into an architecture X X
5.3.2 Develop an architecture for the interfaces of software items X X
5.3.3 Specify functional and performance requirements of SOUP item X X
5.3.4 Specify system hardware and software required by SOUP item X X
5.3.5 Identify segregation necessary for risk control X
5.3.6 Verify software architecture X X
5.4 Software detailed design
5.4.1 Subdivide software into software units X X
5.4.2 Develop detailed design for each software unit X
5.4.3 Develop detailed design for interfaces X
5.4.4 Verify detailed design task X
5.5 Software unit implementation
5.5.1 Implement each software unit X X X
5.5.2 Establish software unit verification process X X
5.5.3 Software unit acceptance criteria X X
5.5.4 Additional software unit acceptance criteria X
5.5.5 Software unit verification X X
5.6 Software Integration and Integration Testing
5.6.1 Integrate software units X X
5.6.2 Verify software integration X X
5.6.3 Software integration testing X X
5.6.4 Software integration testing content X X
5.6.5 Evaluate software integration test procedures X X
5.6.6 Conduct regression tests X X
5.6.7 Integration test record contents X X
5.6.8 Use software problem resolution process X X
5.7 Software system testing
5.7.1 Establish tests for software requirements * X X X
5.7.2 Use software problem resolution process * X X X
5.7.3 Retest after changes * X X X
5.7.4 Evaluate software system testing * X X X
5.7.5 Software system test record contents * X X X
5.8 Software release for utilization at a system level
5.8.1 Ensure software verification is complete * X X X
5.8.2 Document known residual anomalies * X X X
5.8.3 Evaluate known residual anomalies X X
5.8.4 Document released versions X X X
5.8.5 Document how released software was created X X
5.8.6 Ensure activities and tasks are complete X X
5.8.7 Archive software * X X X
5.8.8 Assure reliable delivery of released software * X X X
6 Software maintenance process

6.1 Establish software maintenance plan X X X

6.2 Problem and Modification
6.2.1 Document and evaluate feedback
6.2.1.1 Monitor feedback X X X
6.2.1.2 Document and evaluate feedback X X X
6.2.1.3 Evaluate problem report's affects on safety X X X
6.2.2 Use software problem resolution process X X X
6.2.3 Analyze change requests * X X X
6.2.4 Change request approval X X X
6.2.5 Communicate to users and regulators X X X
6.3 Modification Implementation
6.3.1 Use established process to implement modification X X X
6.3.2 Re-release modified software system X X X
SUPPORTING PROCESSES
7 Software risk management process
7.1 Analysis of software contributing to hazardous situations
7.1.1 Identify software items that could contribute to a hazardous situation X X
7.1.2 Identify potential causes of contribution to a hazardous situation X X
7.1.3 Review published SOUP anomaly lists X X
7.1.4 Document potential causes X X
7.1.5 Document sequences of events *
7.2 Risk control measures
7.2.1 Define Risk control measures X X
7.2.2 Risk control measures implemented in software X X
7.3 Verification of Risk control measures
7.3.1 Verify Risk control measures X X
7.3.2 Document any new sequences of events *
7.3.3 Document traceability X X
7.4 Risk management of software changes
7.4.1 Analyze changes to medical device software with respect to safety X X X
7.4.2 Analyze impact software changes on existing risk control measures X X
7.4.3 Perform risk management activities based on analyses X X
8 Software configuration management Process
8.1 Configuration identification
8.1.1 Establish means to identify configuration items X X X
8.1.2 Identify SOUP X X X
8.1.3 Identify system configuration documentation X X X
8.2 Change control
8.2.1 Approve Change requests X X X
8.2.2 Implement changes X X X
8.2.3 Verify changes X X X
8.2.4 Provide means for traceability of change X X X
8.3 Configuration status accounting
8.3.1 Configuration status accounting task X X X
9 Software problem resolution Process
9.1 Prepare problem reports X X X
9.2 Investigate the problem X X X
9.3 Advise relevant parties X X X
9.4 Use change control process X X X
9.5 Maintain records X X X
9.6 Analyze problems for trends X X X
9.7 Verify software problem resolution X X X
9.8 Test documentation contents X X X
SOP Section