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    Quality & RiskQuality System

    Change Control

    Formal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance.

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

    Definition

    Change control evaluates proposed changes to design, processes, suppliers, software, or labeling for impact on safety, performance, regulatory status, and validation status before approval and implementation.

    What this means in practice

    Tightly linked to Letter-to-File decisions, supplier change notifications, and PCCP boundaries for AI devices. Inadequate change-impact assessments are a frequent FDA inspection finding.

    Cross-references

    Uses

    Concepts or artefacts this term builds on.

    See also

    Closely related context worth reading.

    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(i)
      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.