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    Quality & RiskQuality SystemDHF

    Design History File

    Compilation of records describing the design history of a finished device.

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

    Definition

    The Design History File (DHF) contains or references the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the design control requirements of 21 CFR 820.30.

    What this means in practice

    The DHF is a key inspection artifact. Under the upcoming QMSR, the DHF concept is harmonized with ISO 13485's design and development records.

    Cross-references

    Contains

    Sub-elements or required artefacts of this term.

    Primary references

    3 sources
    Link health: 2 verified 1 needs review· last checked 2026-05-09
    eCFR·1FDA·1ISO·1
    1. 1
      21 CFR 820.30(j)
      Needs review
      eCFRecfr.gov
    2. 2
      FDA - Quality Systems
      Verified
      FDAfda.gov
    3. 3
      ISO 13485 Standard Page
      Verified
      ISOiso.org

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