IEC 62304:2015 Medical Device Software Lifecycle Processes

The manufacturer shall apply a quality management system to the processes covered by this standard. If the manufacturer does not have such a system, at minimum risk management, configuration management, and problem resolution processes shall be established.

• Software development plan
• Software requirements specification
• Architecture description
• Verification report
• Problem report log

• SOUP inventory incomplete
• Traceability gaps
• Problem trend analysis missing

The manufacturer's risk management activities shall be performed as defined in ISO 14971. Software is considered a contributing factor to hazardous situations and must be addressed in risk management.

• Software development plan
• Software requirements specification
• Architecture description
• Verification report
• Problem report log

• SOUP inventory incomplete
• Traceability gaps
• Problem trend analysis missing

Assign software safety class A, B, or C based on possible harm contribution and document the rationale.

• Safety class assignment memo
• Risk file linkage
• Justification table

• Class assigned without hazard analysis
• No reclassification after design change

If software is legacy software that cannot comply with this standard, perform risk management, gap analysis, and implement a plan to mitigate risks introduced by gaps in documentation and process.

• Software development plan
• Software requirements specification
• Architecture description
• Verification report
• Problem report log

• SOUP inventory incomplete
• Traceability gaps
• Problem trend analysis missing

Plan the software development activities, specifying processes, deliverables, traceability, risk management, documentation requirements, configuration management, and verification/validation strategies.

• Software development plan
• Software requirements specification
• Architecture description
• Verification report
• Problem report log

• SOUP inventory incomplete
• Traceability gaps
• Problem trend analysis missing

Derive and document software requirements from system requirements including functional, performance, interface, security, and risk control requirements.

• SRS document
• Trace matrix system to software
• Review minutes

• Risk control requirements missing
• Untraceable items

Develop and document software architecture identifying items, interfaces, and segregation needed to support risk control measures.

• Architecture diagrams
• Item interface descriptions
• Segregation rationale for Class C

• No segregation rationale
• Interfaces not specified for SOUP

For Class C software, develop detailed design for each software unit and document interfaces between units.

• Unit design documents
• Interface specifications
• Design review records

• Detailed design absent for Class C
• No unit interface definition

Implement each software unit and verify against unit acceptance criteria using documented procedures.

• Code with version control
• Unit test reports
• Acceptance criteria checklist

• Acceptance criteria not defined
• No evidence of unit verification for Class B/C

Integrate software units according to plan and test integration including regression testing after changes.

• Integration test procedures
• Test execution logs
• Regression test results

• No regression after changes
• Integration tests not linked to design

Perform system testing to verify software requirements are met and document results with traceability to requirements.

• System test cases
• Pass/fail records
• Trace to SRS

• Requirements not fully tested
• Anomalies not classified

Document the version of released software, residual anomalies, and ensure build is repeatable before release.

• Release notes
• Known anomaly list
• Build environment archive

• No archived build environment
• Anomalies not evaluated against safety

Establish maintenance plan to handle problem reports, modifications, and re-release of software after market release.

• Maintenance procedure
• Problem report workflow
• Change control linkage

• Maintenance plan missing
• No link to post-market surveillance

Analyse feedback and problem reports to determine impact on safety and required modifications.

• Problem report register
• Safety impact analyses
• CAPA links

• Safety impact not documented
• No customer feedback ingestion

Implement modifications using the established development process. Use the software development process activities appropriate to the modification being made.

• Software development plan
• Software requirements specification
• Architecture description
• Verification report
• Problem report log

• SOUP inventory incomplete
• Traceability gaps
• Problem trend analysis missing

Identify software items that could contribute to hazardous situations and document potential causes including SOUP failures.

• Software hazard analysis
• SOUP failure list
• Trace to ISO 14971 risk file

• SOUP failures not analysed
• Hazard analysis disconnected from risk file

Define risk control measures implemented in software and verify their effectiveness through testing and analysis.

• Risk control list
• Verification test results
• Trace from control to requirement

• Controls not verified
• No trace to specific requirement

Verify each risk control measure implemented in software and document the verification activities and results.

• Verification procedures
• Verification reports
• Sign-off records

• Verification incomplete
• No independent review

Analyse changes to software for impact on existing risk controls and on safety classification.

• Change impact assessment
• Reclassification record if needed
• Regression test plan

• Change impact superficial
• No reclassification check

Establish a scheme to uniquely identify configuration items including SOUP and supporting tools.

• Configuration management plan
• Item list with IDs
• Tool inventory

• Tools not under configuration control
• SOUP versions not pinned

Approve changes through documented procedure including impact analysis, verification, and traceability.

• Change request log
• Impact analysis records
• Approval signatures

• Emergency changes not retroactively recorded
• Approver independence weak

Maintain records of configuration item status, change history, and current baselines.

• Configuration status report
• Baseline definitions
• Change log export

• Baselines not labelled
• Status reports out of date

When a software problem is detected, create a problem report. The problem report shall document the problem including steps to reproduce, severity, and criticality.

• Software development plan
• Software requirements specification
• Architecture description
• Verification report
• Problem report log

• SOUP inventory incomplete
• Traceability gaps
• Problem trend analysis missing

Investigate each problem report to determine the scope, severity, and root cause. Evaluate the problem's impact on previously released software.

• Software development plan
• Software requirements specification
• Architecture description
• Verification report
• Problem report log

• SOUP inventory incomplete
• Traceability gaps
• Problem trend analysis missing

Advise relevant parties (regulatory authorities, users, manufacturers) of the existence of the problem as appropriate. Document and track advisories.

• Software development plan
• Software requirements specification
• Architecture description
• Verification report
• Problem report log

• SOUP inventory incomplete
• Traceability gaps
• Problem trend analysis missing

Use the change control process to approve and implement required changes. Verify that changes resolve the problem without introducing new problems.

• Software development plan
• Software requirements specification
• Architecture description
• Verification report
• Problem report log

• SOUP inventory incomplete
• Traceability gaps
• Problem trend analysis missing

Maintain records of the analysis and resolution of each problem. Include trend analysis of problem reports to identify systematic issues.

• Software development plan
• Software requirements specification
• Architecture description
• Verification report
• Problem report log

• SOUP inventory incomplete
• Traceability gaps
• Problem trend analysis missing

Analyze problem reports to detect trends. Identify issues that may indicate systematic software quality problems requiring corrective action.

• Software development plan
• Software requirements specification
• Architecture description
• Verification report
• Problem report log

• SOUP inventory incomplete
• Traceability gaps
• Problem trend analysis missing

Verify that each problem resolution is implemented and that no additional problems have been introduced. Document the verification results.

• Software development plan
• Software requirements specification
• Architecture description
• Verification report
• Problem report log

• SOUP inventory incomplete
• Traceability gaps
• Problem trend analysis missing

Document the test activities performed to verify problem resolution, including test procedures, expected results, actual results, and pass/fail criteria.

• Software development plan
• Software requirements specification
• Architecture description
• Verification report
• Problem report log

• SOUP inventory incomplete
• Traceability gaps
• Problem trend analysis missing

Establish and maintain a software development plan covering processes, deliverables, and traceability for the safety class.

• Software development plan
• Tailoring matrix by class
• Approval signatures

• Plan not updated when scope changes
• No mapping of activities to safety class

Identify Software of Unknown Provenance items with title, version, and manufacturer, and document functional and performance requirements.

• SOUP register
• Anomaly list review
• Version pinning evidence

• No SOUP inventory
• Anomaly list not reviewed against intended use

Establish a process to receive, document, evaluate, and resolve software problems and to verify resolutions.

• Problem tracking system
• Verification of fix
• Communication to stakeholders

• Fixes not verified before close
• No trend analysis