MEDICAL DEVICE BOM REGULATORY COMPLIANCE CHECKLIST

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--- DOCUMENT CONTROL & TRACEABILITY ---
[ ] Document Creation Date
[ ] Document Revision Number
[ ] Last Revision Date
[ ] Revision Summary (Describe Changes)
[ ] Document Status (e.g., Draft, Approved, Released) (Draft, Approved, Released, Obsolete)
[ ] Approval Status (Pending Approval, Approved, Rejected)
[ ] Approver Signature
[ ] Unique Document Identifier

--- MATERIAL IDENTIFICATION & SPECIFICATIONS ---
[ ] Part Number
[ ] Material Description
[ ] Quantity per Assembly
[ ] Material Specification Notes
[ ] Material Certificate of Analysis
[ ] Material Status (Active/Inactive/Obsolete) (Active, Inactive, Obsolete)
[ ] Date of Last Specification Update

--- SUPPLIER MANAGEMENT & QUALIFICATION ---
[ ] Supplier Certification Status (Certified (ISO 13485/Equivalent), Pending Certification, Not Applicable)
[ ] Supplier Approval Score
[ ] Supplier Quality Agreement
[ ] Supplier Audit Findings
[ ] Last Supplier Audit Date
[ ] Material Origin Verification (Verified, Pending Verification, Not Applicable)

--- CHANGE CONTROL & IMPACT ASSESSMENT ---
[ ] Description of BOM Change
[ ] Change Category (Material, Supplier, Quantity, Specification, Design)
[ ] Estimated Cost Impact (USD)
[ ] Proposed Implementation Date
[ ] Regulatory Impact (Initial Assessment) (None, Minor, Moderate, Major)
[ ] Supporting Documentation (e.g., Specification Changes)
[ ] Reason for Change

--- RISK ASSESSMENT & MITIGATION ---
[ ] Identify Potential Material Risks (e.g., availability, obsolescence, substitution impact)
[ ] Risk Severity Score (1-10, 1=Low, 10=High)
[ ] Probability of Occurrence (1-10, 1=Rare, 10=Frequent)
[ ] Risk Category (Material Sourcing, Supply Chain Disruption, Quality Deviation, Regulatory Non-Compliance) (Material Sourcing, Supply Chain Disruption, Quality Deviation, Regulatory Non-Compliance)
[ ] Describe Mitigation Strategy (Specific actions to reduce risk)
[ ] Planned Mitigation Implementation Date
[ ] Risk Status (Open, In Progress, Completed, Rejected) (Open, In Progress, Completed, Rejected)
[ ] Supporting Documentation (e.g., supplier audits, test reports)

--- DESIGN HISTORY FILE (DHF) ALIGNMENT ---
[ ] Summary of BOM Integration with DHF
[ ] DHF Document Number
[ ] BOM Version Included in DHF? (Yes, No, N/A)
[ ] Screenshot of DHF BOM Reference
[ ] Date of Last DHF BOM Review
[ ] Description of any Discrepancies & Resolution
[ ] BOM Changes Reconciled with DHF? (Yes, No, Pending)

--- PROCESS VALIDATION & VERIFICATION ---
[ ] Batch Number of Validated Process
[ ] Process Validation Start Date
[ ] Process Validation Completion Date
[ ] Validation Protocol Summary
[ ] Validation Protocol Document
[ ] Validation Status (Approved, Rejected, Pending Review)
[ ] Number of Validation Runs

--- LABELING & PACKAGING COMPLIANCE ---
[ ] Product Name as per Labeling Requirements
[ ] Model Number as per Labeling Requirements
[ ] Labeling Instructions and Regulations Applied
[ ] Sample Label Design
[ ] Packaging Material Compliant? (Yes, No, N/A)
[ ] Label Dimensions (Width)
[ ] Label Dimensions (Height)
[ ] Label Approval Date

--- RECORDS MANAGEMENT & RETENTION ---
[ ] Record Creation Date
[ ] Record Identifier/Document Control Number
[ ] Description of Record/Document
[ ] Record Type (e.g., BOM, Specification, Certificate) (BOM, Specification, Certificate, Supplier Agreement, Change Order)
[ ] Record Retention Expiration Date
[ ] Notes/Comments (e.g., justification for extended retention)
[ ] Record Custodian Signature
[ ] Physical Storage Location (if applicable)

--- INTERNAL AUDIT & CONTINUOUS IMPROVEMENT ---
[ ] Audit Completion Date
[ ] Number of Non-Conformances Identified
[ ] Summary of Audit Findings
[ ] Areas Requiring Improvement (Select all that apply) (Documentation Control, Supplier Management, Change Control, Training, System Integration)
[ ] Corrective Action Plan - Description
[ ] Corrective Action Completion Date
[ ] Audit Lead Signature
[ ] Audit Lead Name

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