Medical Device Design Review Form

Project Information

Project Name Device Name Model/Version Date of Review Review Number

Team Members Present

Design Stage

Concept Design Input Design Output Verification Validation Transfer Other

Review Items

Item	Discussion/Notes	Status	Action Required
Design Inputs
Design Outputs
Risk Management
Verification/Validation
Regulatory Requirements
Other

Open Issues

Action Items

Action Item	Owner	Due Date	Status

Conclusions & Recommendations

Sign-Offs

Name	Role/Title	Signature	Date