Medical Device BOM Regulatory Compliance Checklist

Document Control & Traceability

1 of 10

Ensures proper versioning, approval workflows, and audit trails for all BOM documents.

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

2 of 10

Verifies accuracy and completeness of material descriptions, part numbers, and technical 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

3 of 10

Confirms supplier certifications, quality agreements, and material origin tracking.

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

4 of 10

Evaluates the regulatory impact of BOM changes and ensures proper documentation and approval.

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

5 of 10

Identifies potential risks associated with materials and processes, and implements appropriate mitigation strategies.

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

6 of 10

Ensures BOM data is consistent and integrated with the Design History File for regulatory submissions.

Summary of BOM Integration with DHF

DHF Document Number

BOM Version Included in DHF?

Yes

N/A

Screenshot of DHF BOM Reference

Date of Last DHF BOM Review

Description of any Discrepancies & Resolution

BOM Changes Reconciled with DHF?

Yes

Pending

Process Validation & Verification

7 of 10

Confirms that the BOM accurately reflects validated manufacturing processes and equipment.

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

8 of 10

Verifies accuracy of labeling information and compliance with packaging requirements.

Product Name as per Labeling Requirements

Model Number as per Labeling Requirements

Labeling Instructions and Regulations Applied

Sample Label Design

Packaging Material Compliant?

Yes

N/A

Label Dimensions (Width)

Label Dimensions (Height)

Label Approval Date

Records Management & Retention

9 of 10

Defines procedures for storing, managing, and retaining BOM-related records in compliance with regulations.

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

10 of 10

Establishes a process for periodic internal audits and ongoing improvements to the BOM management system.

Document Control & Traceability

Document Creation Date

Document Revision Number

Last Revision Date

Revision Summary (Describe Changes)

Document Status (e.g., Draft, Approved, Released)

Approval Status

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)

Date of Last Specification Update

Supplier Management & Qualification

Supplier Certification Status

Supplier Approval Score

Supplier Quality Agreement

Supplier Audit Findings

Last Supplier Audit Date

Material Origin Verification

Change Control & Impact Assessment

Description of BOM Change

Change Category

Estimated Cost Impact (USD)

Proposed Implementation Date

Regulatory Impact (Initial Assessment)

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)

Describe Mitigation Strategy (Specific actions to reduce risk)

Planned Mitigation Implementation Date

Risk Status (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?

Screenshot of DHF BOM Reference

Date of Last DHF BOM Review

Description of any Discrepancies & Resolution

BOM Changes Reconciled with DHF?

Process Validation & Verification

Batch Number of Validated Process

Process Validation Start Date

Process Validation Completion Date

Validation Protocol Summary

Validation Protocol Document

Validation Status

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?

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)

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