Biomedical Device Quality Non-Conformance Report
Report Number
Date
Reported By
Device Information
Device Name
Model/Type
Serial/Lot No.
Manufacturer
Non-Conformance Details
Description of Non-Conformance
Detected At (Location/Department)
Date Detected
Impact/Effect
Risk Assessment
Immediate Actions Taken
Root Cause Analysis
Corrective / Preventive Actions
Follow-Up / Verification
Follow-Up By
Follow-Up Date
Verification/Comments
Approvals
Reviewed By
Date
Approved By
Date