T-012-021 Product Design Phase 1 Checklist
Process Overview
The purpose of the Product Design checklist (phase 1) review is to ensure the outputs of Product Design satisfy the criteria listed in the next section.
Project Informations
- Project title:
- Project manager (name and function):
Context of Initialization of the Product Design Project
Instructions
Briefly explain why the project was initiated and what problem it addresses. Include:
- The purpose and intended use of the product.
- The medical or operational need it solves.
- Key technological elements (e.g., ML, UI, etc.) involved in the solution.
- A summary of previous versions or iterations (if applicable).
- Any regulatory or market-specific context (e.g., clinical trials, target countries).
Keep the description clear and focused on justifying the project's start.
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 |
General Presentation of the Project
Checklist Design Review
- Description of the device
- Description of the Intended Use: yes/no
- Device Description: yes/no
- Product requirements
- List of product requirements: yes/no
- Are they complete? yes/no
- Are they understandable? yes/no
- Are they consistent? yes/no
- Are they feasible? yes/no
- Do they not contradict one another? yes/no
- Are they uniquely identified? yes/no
Project Perimeter
-
Does the intended product meet the definition of a medical device or medical device accessory?
- yes/no
-
If MD perimeter:
- Estimated medical device class (MDR):
- Estimated medical device class (FDA):
- Estimated software class (NF/EN 62304):
- Estimated software class (FDA):
Others Expected Requirements
- Not applicable
Reserves
N° | Documents / Purpose / Actions to implement | Owner | Targeted Date |
---|---|---|---|
1 |
Conclusion
Instructions
Summarize the outcome of the phase 1 design review. Indicate whether:
- The design inputs and outputs are complete, available, and relevant.
- The project is ready to move forward to the next phase based on the information reviewed.
- There are any notable comments or conclusions from the reviewers.
Keep the language concise and focused on decision-readiness.