This checklist provides a comprehensive review of compliance with the EN IEC 82304-1:2016 standard for health software - Part 1: General requirements for product safety. This standard applies to health software products intended to be used by patients or healthcare providers.
| Field | Value |
|---|
| Product Name | |
| Version | |
| Checklist Prepared By | |
| Checklist Prepared Date | |
| Checklist Reviewed By | |
| Checklist Review Date | |
| Checklist Approved By | |
| Checklist Approval Date | |
4. General Requirements
| Clause | Requirement | Fulfilled | Evidence/Comments |
|---|
| 4.1 | The manufacturer shall implement a quality management system | ☐ | |
| 4.2 | The manufacturer shall have a risk management system | ☐ | |
5. Safety and Security Requirements
5.1 Health software safety requirements
| Clause | Requirement | Fulfilled | Evidence/Comments |
|---|
| 5.1.1 | Establish and document a health software safety specification | ☐ | |
| 5.1.2 | The health software safety specification shall be derived from the intended use | ☐ | |
5.2 Data created, processed and exported by health software
| Clause | Requirement | Fulfilled | Evidence/Comments |
|---|
| 5.2.1 | Maintain integrity of data throughout health software lifecycle | ☐ | |
| 5.2.2 | Prevent corruption of data | ☐ | |
| 5.2.3 | Provide means for backing up and restoring data | ☐ | |
| 5.2.4 | Document retention requirements for data | ☐ | |
5.3 Validation of software used in the health software development process
| Clause | Requirement | Fulfilled | Evidence/Comments |
|---|
| 5.3.1 | Validate software tools used in health software development | ☐ | |
| 5.3.2 | Maintain records of validation | ☐ | |
6. Product Lifecycle Requirements
6.1 Health software development lifecycle
| Clause | Requirement | Fulfilled | Evidence/Comments |
|---|
| 6.1.1 | Establish and document health software development lifecycle | ☐ | |
| 6.1.2 | Define outputs for each phase of the lifecycle | ☐ | |
| 6.1.3 | Define verification activities for each output | ☐ | |
6.2 Health software validation
| Clause | Requirement | Fulfilled | Evidence/Comments |
|---|
| 6.2.1 | Validate health software before initial release | ☐ | |
| 6.2.2 | Demonstrate that the software product satisfies user requirements | ☐ | |
| 6.2.3 | Conduct validation in the intended environment of use | ☐ | |
| 6.2.4 | Document validation results | ☐ | |
6.3 Health software maintenance
| Clause | Requirement | Fulfilled | Evidence/Comments |
|---|
| 6.3.1 | Establish software maintenance processes | ☐ | |
| 6.3.2 | Document maintenance activities | ☐ | |
| 6.3.3 | Perform impact analysis for software changes | ☐ | |
| 6.3.4 | Update health software documentation | ☐ | |
6.4 Health software decommissioning
| Clause | Requirement | Fulfilled | Evidence/Comments |
|---|
| 6.4.1 | Plan for health software decommissioning | ☐ | |
| 6.4.2 | Preserve data during decommissioning | ☐ | |
| 6.4.3 | Provide instructions for data migration | ☐ | |
7. Product Requirements
7.1 Accompanying documents
| Clause | Requirement | Fulfilled | Evidence/Comments |
|---|
| 7.1.1 | Provide instructions for use | ☐ | |
| 7.1.2 | Include product identification in accompanying documents | ☐ | |
| 7.1.3 | Describe intended use | ☐ | |
| 7.1.4 | Identify intended users | ☐ | |
| 7.1.5 | Specify IT environment for proper function | ☐ | |
| 7.1.6 | Describe minimum system requirements | ☐ | |
| 7.1.7 | Provide installation and setup instructions | ☐ | |
| 7.1.8 | Provide user training if required | ☐ | |
| 7.1.9 | Specify conditions for installation, use, and maintenance | ☐ | |
| 7.1.10 | Describe data backup and recovery procedures | ☐ | |
| 7.1.11 | Describe health software updates | ☐ | |
| 7.1.12 | Provide cybersecurity guidance | ☐ | |
| 7.1.13 | Identify known residual risks | ☐ | |
| 7.1.14 | Provide information on how to report problems | ☐ | |
7.2 Installation and deployment
| Clause | Requirement | Fulfilled | Evidence/Comments |
|---|
| 7.2.1 | Verify successful installation | ☐ | |
| 7.2.2 | Provide mechanism to verify integrity of health software | ☐ | |
7.3 Updates and patches
| Clause | Requirement | Fulfilled | Evidence/Comments |
|---|
| 7.3.1 | Provide means to deliver updates and patches | ☐ | |
| 7.3.2 | Inform users about availability of updates | ☐ | |
| 7.3.3 | Describe the purpose and content of updates | ☐ | |
8. Problem Resolution
| Clause | Requirement | Fulfilled | Evidence/Comments |
|---|
| 8.1 | Establish process for receiving user feedback | ☐ | |
| 8.2 | Establish process for problem resolution | ☐ | |
| 8.3 | Provide information about known problems | ☐ | |
| 8.4 | Provide timely information about critical safety issues | ☐ | |
Summary
| Section | Total Items | Fulfilled | Percentage |
|---|
| 4. General Requirements | 2 | | % |
| 5. Safety and Security | | | % |
| 6. Lifecycle Requirements | | | % |
| 7. Product Requirements | | | % |
| 8. Problem Resolution | 4 | | % |
| 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.
| Item Reference | Description | Responsible | Target Date | Status |
|---|
| | | | |
Approvals
| Role | Name | Signature | Date |
|---|
| Checklist Prepared By | | | |
| Checklist Reviewed By | | | |
| Checklist Approved By | | | |
End of EN 82304 Checklist