Medical Device Engineering Change Request (ECR) Form
General Information
ECR Number
Date
Requested By
Department
Device/Product Name
Model/Part Number
Description of Change
Type of Change
Design
Material
Process
Documentation
Other
Change Description
Reason for Change
Proposed Implementation Date
Affected Documents/Parts
Impact Assessment
Regulatory Impact
Yes
No
Unknown
Quality Impact
Yes
No
Unknown
Other Potential Impacts
Review & Approval
Initiator
Date
Engineering
Date
Quality
Date
Regulatory
Date
Management
Date