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    Risk & Usability Deep Dive

    ISO 14971 risk management paired with IEC 62366-1 usability engineering, the two lifecycle standards regulators expect on every device.

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    1. 1
      Standards

      ISO 14971

      International standard for the application of risk management to medical devices.

      Why this term here: The foundation. Everything else in this path connects back to it.

    2. 2
      Quality & Risk

      Risk Management File(RMF)

      Set of records and outputs from the ISO 14971 risk management process.

      Why this term here: The living compilation regulators inspect first when they arrive.

    3. 3
      Quality & Risk

      Risk Acceptability Matrix

      Pre-defined matrix mapping severity × probability combinations to acceptable, ALARP, or unacceptable risk.

      Why this term here: Your policy on what risk you will and will not tolerate.

    4. 4
      Standards

      IEC 62366-1

      Application of usability engineering to medical devices.

      Why this term here: The lifecycle process for usability engineering.

    5. 5
      Clinical & Trials

      Human Factors Engineering(HFE)

      Engineering discipline focused on safe and effective device use by intended users.

      Why this term here: FDA's parallel expectation set for user-interface risk.

    6. 6
      Quality & Risk

      Use Specification

      Defined description of intended users, uses, use environments, and patient populations for a device.

      Why this term here: The written scope of intended users, uses, and environments.

    7. 7
      Clinical & Trials

      Use Error

      User action or lack thereof that leads to a different result than intended by the manufacturer or expected by the user.

      Why this term here: How the standard defines use-related risks distinct from misuse.

    8. 8
      Quality & Risk

      Summative vs. Formative Evaluation

      Iterative usability studies (formative) vs. final validation testing (summative) of a device's user interface.

      Why this term here: The two study types and where each belongs in the design cycle.

    9. 9
      Regulatory

      Labeling

      All written, printed, or graphic matter on or accompanying a device.

      Why this term here: The final risk control most teams underestimate.

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