Medical Device Software Release Approval Form

General Information

Project Name

Device Name

Software Version

Release Date

Release Type

Release Details

Description of Release Summary of Changes Impact Assessment

Verification & Validation

Item	Status	Reviewed By	Date
Test Plan Executed
Test Results Reviewed
Risk Assessment Updated
Release Notes Prepared

Approvals

Role	Name	Signature	Date
Software Project Manager
Quality Assurance
Regulatory Affairs
Other

Comments