Medical Device Design Review Checklist

Project Name Device Name Design Review Date Location Review Leader Attendees

Checklist Item	Yes/No	Comments
User Needs Defined and Addressed	Yes No
Design Inputs Reviewed	Yes No
Design Outputs Verified	Yes No
Risk Analysis Performed	Yes No
Regulatory Requirements Considered	Yes No
Verification and Validation Plans	Yes No
Design Changes Documented	Yes No
Action Items Identified	Yes No

General Comments

Action Items (if any)

Review Leader Signature Date