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    Design Transfer

    Translating design into production specifications.

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

    Definition

    Design transfer ensures that the device design is correctly translated into production specifications, per 21 CFR 820.30(h). It bridges product development and manufacturing.

    What this means in practice

    Premature or poorly executed design transfer is a top cause of post-launch quality issues.

    Cross-references

    Follows

    Comes after in a typical workflow or lifecycle.

    Primary references

    3 sources
    Link health: 2 verified 1 needs review· last checked 2026-05-09
    eCFR·1IMDRF/GHTF·1FDA·1
    1. 1
      21 CFR 820.30(h)
      Needs review
      eCFRecfr.gov
    2. 2
      GHTF/IMDRF Process Validation Guidance
      Verified
      IMDRF/GHTFimdrf.org
    3. 3
      FDA - Device Manufacturing
      Verified
      FDAfda.gov

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