MedTech Terms
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    All pathsQA · Operations · 10 terms

    QMS Foundations

    Quality system terminology grounded in QSR, the upcoming QMSR, and ISO 13485.

    1. 1
      Quality & Risk

      Quality System Regulation(QSR / 21 CFR 820)

      FDA's current good manufacturing practice (cGMP) requirements for medical devices.
    2. 2
      Quality & Risk

      Quality Management System Regulation(QMSR)

      FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference.
    3. 3
      Standards

      ISO 13485

      International standard for medical device quality management systems.
    4. 4
      Quality & Risk

      Design Controls

      Structured process governing the design of medical devices.
    5. 5
      Quality & Risk

      Verification & Validation(V&V)

      Confirming design outputs meet inputs (V) and that devices meet user needs (V).
    6. 6
      Quality & Risk

      Design History File(DHF)

      Compilation of records describing the design history of a finished device.
    7. 7
      Quality & Risk

      Corrective and Preventive Action(CAPA)

      Systematic process to investigate and resolve quality issues and prevent recurrence.
    8. 8
      Quality & Risk

      Complaint Handling

      Process for receiving, evaluating, and responding to device complaints.
    9. 9
      Quality & Risk

      FDA Form 483

      Notice of inspectional observations issued at the conclusion of an FDA inspection.
    10. 10
      Quality & Risk

      Warning Letter

      Formal FDA notification of significant violations requiring prompt corrective action.

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