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.