Verify documentation completeness and process compliance before releasing medical device software versions.
Item | Yes / No | Comment |
---|---|---|
The Software Requirement List and Software Requirements List Checklist have been completed to ensure design specification has occurred. | Yes | Updated requirements for new AI algorithms documented in SRL-2024-003 |
All relevant risks (including risks of known anomalies) have been evaluated; the Risk Management Report is complete. | Yes | Risk assessment updated for AI algorithm changes, no new unacceptable risks identified |
Software verification in the form of code review and Software System Test Plan and Software System Test Reports have been completed if needed. | Yes | Code review completed for all AI algorithm changes, system testing passed all acceptance criteria |
Design control traceability has been implemented | Yes | Traceability matrix updated to reflect new requirements and test cases |
A version number as defined in the Software Development and Maintenance Plan has been assigned and added as a tag to git. | Yes | Version 2.1.0 tagged in Git repository on March 10, 2024 |
Software is registered with the competent authority and with a Notified Body if Class Im/Ir/Is, Class IIa, Class IIb and Class III. | Yes | Class IIa device registered with TÜV SÜD, registration updated for new version |
If release includes a significant change: Notified Body has been informed. | No | Changes assessed as non-significant, no notified body notification required |
Label is applied correctly including CE mark | Yes | Device label updated with new version number and release date |
Document Name | Document Number | Updated | Justification for no update |
---|---|---|---|
User Needs List | UNL-2024-001 | No | AI algorithm improvements don’t change fundamental user needs |
Intended Use | IU-2024-001 | No | Diagnostic imaging purpose remains unchanged |
Risk Management Plan | RMP-2024-001 | Yes | Updated to include AI algorithm risk assessment procedures |
Risk Assessment | RA-2024-002 | Yes | New risks evaluated for AI algorithm changes |
Risk Management Report | RMR-2024-002 | Yes | Updated with AI algorithm risk evaluation results |
System Requirements List | SRL-2024-003 | Yes | New requirements added for enhanced AI algorithms |
Software Architecture | SA-2024-002 | Yes | Architecture updated to reflect AI algorithm integration |
Software System Test Plan | SSTP-2024-002 | Yes | New test cases added for AI algorithm functionality |
Software System Test Report | SSTR-2024-002 | Yes | Test results documented for version 2.1.0 |
Instructions for Use | IFU-2024-001 | Yes | Updated to describe new AI algorithm features |
Release Notes | RN-2024-002 | Yes | New release notes created for version 2.1.0 |
Device Label | DL-2024-002 | Yes | Updated with new version number and release date |
What should I do if I discover missing documentation during the release checklist?
How do I determine if my software changes are significant enough to require notified body notification?
What happens if I need to update documentation after completing the release checklist?
How often should I update my software release checklist template?
Can I release software if some documentation updates are marked as 'No' in the checklist?
How do I handle version control for the release checklist itself?