EN 62304 Checklist

This checklist provides a comprehensive review of compliance with the EN ISO 62304:2006/A1:2015 standard for medical device software lifecycle processes. The checklist is structured according to the major clauses of the standard and should be completed as part of the quality management system documentation for the device.

Document Information

Field	Value
Product Name
Version
Checklist Prepared By
Checklist Prepared Date
Checklist Reviewed By
Checklist Review Date
Checklist Approved By
Checklist Approval Date

Software Safety Classification

Software safety classification

According to IEC 62304, the device can be classified as a Class B medical device. As such, not all the items of the checklist are required. When an item is required, it will be noted in the column Required of the following table.

Primary Lifecycle Processes

4. General Requirements

Reference	Software Lifecycle Process	Required	Fulfilled
4.1	Quality Management System	TRUE	☐
4.2	Risk Management Process	TRUE	☐
4.3	Software safety classification	TRUE	☐
4.4	Legacy software	TRUE	☐

5. Software Development Process

5.1 Software development planning

Reference	Software Lifecycle Process	Required	Fulfilled
5.1.1	Plan software development process	TRUE	☐
5.1.2	Keep plan current	TRUE	☐
5.1.3	Document software development plan	TRUE	☐
5.1.4	Software development standards, methods and tools planning	TRUE	☐
5.1.5	Software integration and integration testing	TRUE	☐
5.1.6	Software verification planning	TRUE	☐
5.1.7	Software risk management planning	TRUE	☐
5.1.8	Documentation planning	TRUE	☐
5.1.9	Software configuration management planning	TRUE	☐
5.1.10	Supporting items to be controlled	TRUE	☐
5.1.11	Software configuration item control before verification	TRUE	☐
5.1.12	Identification and avoidance of common software defects	TRUE	☐

5.2 Software requirements analysis

Reference	Software Lifecycle Process	Required	Fulfilled
5.2.1	Define and document software requirements from system requirements	TRUE	☐
5.2.2	Content of the software requirements	TRUE	☐
5.2.3	Integration of risk control measures into software requirements	TRUE	☐
5.2.4	Re-evaluation of the risk analysis of the medical device	TRUE	☐
5.2.5	Update of system requirements	TRUE	☐
5.2.6	Verification of the software requirements	TRUE	☐

5.3 Software architectural design

Reference	Software Lifecycle Process	Required	Fulfilled	Evidence/Comments
5.3.1	Transform software requirements into an architecture	TRUE	☐
5.3.2	Develop an architecture for the interfaces	TRUE	☐
5.3.3	Specify functional and performance requirements for SOUP	TRUE	☐
5.3.4	Specify hardware and software required for SOUP	TRUE	☐
5.3.5	Identify segregation necessary for risk control	FALSE	☐	Required for class C only
5.3.6	Verify software architecture	TRUE	☐

5.4 Software detailed design

Reference	Software Lifecycle Process	Required	Fulfilled	Evidence/Comments
5.4.1	Subdivide software into software units	TRUE	☐
5.4.2	Develop detailed design for each software unit	FALSE	☐	Required for class C only
5.4.3	Develop detailed design for interfaces	FALSE	☐	Required for class C only
5.4.4	Verify detailed design	FALSE	☐	Required for class C only

5.5 Software unit implementation and verification

Reference	Software Lifecycle Process	Required	Fulfilled	Evidence/Comments
5.5.1	Implement each software unit	TRUE	☐
5.5.2	Establish software unit verification process	TRUE	☐
5.5.3	Document software unit acceptance criteria	TRUE	☐
5.5.4	Document additional software unit acceptance criteria	FALSE	☐	Required for class C only
5.5.5	Document software unit verification results	TRUE	☐

5.6 Software integration and integration testing

Reference	Software Lifecycle Process	Required	Fulfilled
5.6.1	Integrate software units	TRUE	☐
5.6.2	Verify software integration	TRUE	☐
5.6.3	Document integration testing	TRUE	☐
5.6.4	Document test procedure and test case specification	TRUE	☐
5.6.5	Use test procedures for conducting integration testing	TRUE	☐
5.6.6	Document integration test results	TRUE	☐
5.6.7	Document regression tests	TRUE	☐
5.6.8	Use software problem resolution process for anomalies	TRUE	☐

5.7 Software system testing

Reference	Software Lifecycle Process	Required	Fulfilled
5.7.1	Establish tests for software requirements validation	TRUE	☐
5.7.2	Use software problem resolution process for anomalies	TRUE	☐
5.7.3	Retest after changes to software	TRUE	☐
5.7.4	Document software system testing protocol	TRUE	☐
5.7.5	Document software system testing results	TRUE	☐

5.8 Software release

Reference	Software Lifecycle Process	Required	Fulfilled
5.8.1	Ensure software verification is complete	TRUE	☐
5.8.2	Document known residual anomalies	TRUE	☐
5.8.3	Evaluate known residual anomalies	TRUE	☐
5.8.4	Document released version	TRUE	☐
5.8.5	Document how released software was created	TRUE	☐
5.8.6	Ensure activities and tasks are complete	TRUE	☐
5.8.7	Archive software	TRUE	☐
5.8.8	Assure repeatability of software release	TRUE	☐

6. Software Maintenance Process

Reference	Software Lifecycle Process	Required	Fulfilled
6.1	Establish software maintenance plan	TRUE	☐
6.2.1	Develop and document procedures for receiving feedback	TRUE	☐
6.2.1.1	Document feedback evaluation process	TRUE	☐
6.2.2	Determine whether feedback is a problem	TRUE	☐
6.2.3	Provide adverse event information to users	TRUE	☐
6.2.4	Documented feedback	TRUE	☐
6.2.5	Document evaluation of problem reports	TRUE	☐
6.3.1	Use software problem resolution process	TRUE	☐
6.3.2	Analyze change request regarding patient safety	TRUE	☐

7. Software Risk Management Process

Reference	Software Lifecycle Process	Required	Fulfilled
7.1.1	Identify software items that could contribute to a hazardous situation	TRUE	☐
7.1.2	Identify potential causes of contribution to a hazardous situation	TRUE	☐
7.1.3	Evaluate published SOUP anomaly lists	TRUE	☐
7.1.4	Document potential causes in risk management file	TRUE	☐
7.2.1	Define risk control measures	TRUE	☐
7.2.2	Document risk control measures in risk management file	TRUE	☐
7.3.1	Verify risk control measures	TRUE	☐
7.3.2	Document any new sequence of events	TRUE	☐
7.3.3	Document traceability	TRUE	☐
7.4.1	Analyze changes to medical device software with respect to safety	TRUE	☐
7.4.2	Analyze impact of software changes on existing risk analysis	TRUE	☐
7.4.3	Update risk management	TRUE	☐

8. Software Configuration Management Process

Reference	Software Lifecycle Process	Required	Fulfilled
8.1.1	Establishment of means to identify the configuration items	TRUE	☐
8.1.2	Identification of SOUP	TRUE	☐
8.1.3	Identification of system configuration items	TRUE	☐
8.2.1	Approve change requests	TRUE	☐
8.2.2	Implement change control	TRUE	☐
8.2.3	Communicate configuration item changes	TRUE	☐
8.2.4	Provide means for traceability	TRUE	☐
8.3	Configuration status accounting	TRUE	☐

9. Software Problem Resolution Process

Reference	Software Lifecycle Process	Required	Fulfilled
9.1	Prepare problem reports	TRUE	☐
9.2	Investigate the problem	TRUE	☐
9.3	Advise relevant parties	TRUE	☐
9.4	Use change control process	TRUE	☐
9.5	Maintain records	TRUE	☐
9.6	Analyze problems for trends	TRUE	☐
9.7	Verify software problem resolution	TRUE	☐
9.8	Test documentation contents	TRUE	☐

Summary

Section	Total Items	Percentage
4. General Requirements	4	%
5. Software Development		%
6. Software Maintenance		%
7. Software Risk Management		%
8. Configuration Management		%
9. Problem Resolution		%
Total		%

Compliance Statement

☐ Full Compliance: All required items have been fulfilled and documented appropriately.

☐ Partial Compliance: Some items remain unfulfilled. See action plan below.

☐ Non-Compliance: Significant items are unfulfilled. Immediate corrective action required.

Action Plan for Non-Conformities

Item Reference	Description	Responsible	Target Date	Status

Approvals

Role	Name	Signature	Date
Checklist Prepared By
Checklist Reviewed By
Checklist Approved By

End of EN 62304 Checklist

Document Information​

Software Safety Classification​

Primary Lifecycle Processes​

4. General Requirements​

5. Software Development Process​

5.1 Software development planning​

5.2 Software requirements analysis​

5.3 Software architectural design​

5.4 Software detailed design​

5.5 Software unit implementation and verification​

5.6 Software integration and integration testing​

5.7 Software system testing​

5.8 Software release​

6. Software Maintenance Process​

7. Software Risk Management Process​

8. Software Configuration Management Process​

9. Software Problem Resolution Process​

Summary​

Compliance Statement​

Action Plan for Non-Conformities​

Approvals​