MedTech Terms
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    All pathsSoftware · Data · RA · 9 terms

    SaMD & AI/ML Devices

    From SaMD basics to PCCPs and Good Machine Learning Practice for AI-enabled devices.

    1. 1
      Software & AI

      Software as a Medical Device(SaMD)

      Software intended for medical purposes that performs without being part of a hardware device.
    2. 2
      Software & AI

      Software in a Medical Device(SiMD)

      Software embedded in or required to operate a hardware medical device.
    3. 3
      Standards

      IEC 62304

      Lifecycle requirements for medical device software.
    4. 4
      Software & AI

      Software Safety Classification

      IEC 62304 classes A, B, C reflecting potential harm from software failure.
    5. 5
      Software & AI

      Software of Unknown Provenance(SOUP)

      Software not developed for the purpose of being incorporated into a medical device.
    6. 6
      Software & AI

      Clinical Decision Support(CDS)

      Software providing healthcare professionals with knowledge and patient-specific information.
    7. 7
      Software & AI

      Predetermined Change Control Plan(PCCP)

      FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices.
    8. 8
      Software & AI

      Good Machine Learning Practice(GMLP)

      Guiding principles for the development of AI/ML-enabled medical devices.
    9. 9
      Software & AI

      Interoperability

      Ability of devices and systems to exchange and use information.

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