T-012-013 Design stage review
General information
- Device name:
- Device version:
- Participants: Insert full names and job descriptions
- Objective of the design stage review: e.g. Revision of product's requirements
During the design stage review, participation shall include, at a minimum, team members holding job descriptions JD-003, JD-004, and JD-005, along with any additional team members involved in the project.
Documentation
- Documentation reference: Insert reference of document(s) under review
- Assessment: Insert assessment in terms of completeness, clarity, compliance with applicable standard(s)/regulation(s), and any gaps identified during the review
Risk management
Insert a summary of the identified risks and mitigations for the current stage. Summarize whether risks have been adequately controlled at this stage.
Summary of findings and next steps
Insert a summary of any findings encountered during the design review and list the next steps.
Design approval
The design documentation under review is:
- Approved
- Not approved
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003, JD-004
- Approver: JD-001
Delete this section when you create a new record from this template.
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003, JD-004
- Approver: JD-001