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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 the regulation says
    Regulators emphasize technology transfer as a critical process for ensuring product quality and safety, as outlined in FDA 21 CFR 820.50, "Purchasing Controls," and implicitly through requirements for process validation in FDA 21 CFR 820.75. The EU MDR (Regulation (EU) 2017/745) also requires manufacturers to ensure that devices are designed and manufactured in accordance with quality management system principles, which would encompass robust technology transfer processes.

    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.

    Examples

    • A company transfers the manufacturing of a sterile surgical instrument from its pilot production line to a full-scale production facility, requiring re-validation of sterilization cycles and assembly processes.
    • A contract manufacturer takes over the production of an in vitro diagnostic (IVD) reagent, necessitating the transfer of formulation recipes, analytical test methods, and raw material specifications.
    • An organization acquires a new medical device technology and must transfer its design and manufacturing processes from the acquired entity's site to its own, including equipment calibration and software validation.
    Common pitfalls
    • •Failing to involve quality assurance and regulatory affairs early in the technology transfer process can lead to significant delays and non-conformities.
    • •Inadequate documentation of changes and controls during transfer can result in a loss of process understanding and control.
    • •Not performing sufficient re-qualification and re-validation activities at the receiving site often leads to manufacturing inconsistencies and product defects.
    • •Assuming that processes and equipment will perform identically in a new environment without empirical verification is a common and costly mistake.
    • •Underestimating the need for comprehensive training of personnel at the receiving site can compromise manufacturing quality.

    Frequently asked questions

    The primary goal is to ensure that the transferred manufacturing process consistently produces devices that meet all predetermined specifications, quality attributes, and regulatory requirements at the receiving site.
    Grouped by theme

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    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.