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    ManufacturingManufacturing & SupplyBOM

    Bill of Materials

    Structured list of every component, sub-assembly, and quantity needed to manufacture a device.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    BOMs are released as part of the Device Master Record and drive purchasing, planning, costing, and traceability. Engineering, manufacturing, and service BOMs may differ in level of detail.

    What this means in practice

    BOM accuracy is foundational for UDI assignment, lot traceability, and recall scoping; errors propagate broadly.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·2FDA·1
    1. 1
      ISO 13485 §4.2.3
      Verified
      ISOiso.org
    2. 2
      FDA - Device Manufacturing
      Verified
      FDAfda.gov
    3. 3
      ISO 13485 Standard Page
      Verified
      ISOiso.org

    Inline markers like [1] jump to the matching reference above.