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    Technology Transfer (Manufacturing)

    Transfer of validated processes and knowledge from development (or one site) to commercial manufacturing.

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

    Definition

    Tech transfer covers documented transfer of design outputs, process recipes, equipment qualifications, work instructions, and training to the receiving site, typically followed by re-qualification and process validation runs.

    What this means in practice

    Among the highest-risk activities in a device lifecycle - under-resourced tech transfers cause launch delays, scrap, and field issues.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·2IMDRF/GHTF·1
    1. 1
      ISO 13485:2016 §7.5
      Verified
      ISOiso.org
    2. 2
      ISO 13485 Standard Page
      Verified
      ISOiso.org
    3. 3
      GHTF/IMDRF Process Validation Guidance
      Verified
      IMDRF/GHTFimdrf.org

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