T-012-026 Product Validation Phase 5 Checklist
Actors
Name | Title | Meaning | Approved Date & Time |
---|---|---|---|
Change history
Revision | Summary | Date |
---|---|---|
Process overview
The purpose of the Product Validation Phase 5 Checklist review is to ensure the Product satisfy the criteria listed in the next section
Project information
- Project title:
- Project manager (name and function):
Planning
Phase | Object | Done |
---|---|---|
Phase 1 Product Design Review | Establish input data | |
Phase 2 Software Design Review | SRs, Architectural Design and UI Prototypes | |
Phase 3 Software Candidate Release | Coding, integration and test plan | |
Phase 4 Software Verification Review | Software version verified and residual anomalies | |
Phase 5 Product Validation Review | Validation activities, Technical Documentation and DHF |
Previous reserves
Instructions
If there were any reserves or outstanding issues identified during Phase 2, list them here. Include a brief description of each reserve, the actions required to address them, and assign an owner and targeted completion date. See T-012-024 Software Candidate Release Phase 3 Checklist for an example.
N° | Documents / Purpose / Actions to implement | Owner | Targeted Date | Satisfying |
---|---|---|---|---|
Outputs review
Object | Records & Comments | Satisfying | Reserves see |
---|---|---|---|
Version Delivery Description | |||
Clinical Evaluation plan | |||
Clinical Evaluation report | |||
Clinical Investigation report | |||
Usability Report | |||
AI/ML Evaluation Report | |||
Risk Management Report | |||
Cybersecurity Report | |||
Compatible Ultrasound Systems | |||
DMF is updated |
Regulatory requirement review
Key | Summary | Description | Satisfying | Reserves |
---|---|---|---|---|
Reserves
N° | Documents / Purpose / Actions to implement | Owner | Targeted Date |
---|---|---|---|
Comissioning
- Reference of the commissioning record?:
- Does the software version behave as expected on the production environment?: yes/no
- If not, what are the actions taken?:
Conclusion
Distribution countries
Comments
- Does the IFU and labelling contains all expected informations?: yes/no
- Approval for the product certification and registration?: yes/no
- Regarding the mentioned reserves, has the review been accepted?: yes/no