Medical Device Assembly Batch Record
Device Name
Model/Part Number
Batch/Lot Number
Date
Production Order Number
Quantity to Assemble
Quantity Assembled
Production Line/Area
Component Details
Component Name
Part Number
Batch/Lot No.
Qty Used
Inspected By
Assembly Steps
Step No.
Description
Performed By
Date
Comments
In-Process Inspection
Inspection Point
Criteria
Result
Inspected By
Date
Comments / Deviations
Final Release / Approval
Assembled By
Date
Inspected By
Date
Approved By
Date