MedTech Terms
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    Software Team Onboarding

    What software engineers joining a MedTech team need to know: IEC 62304 lifecycle, SOUP, cybersecurity under Section 524B, and AI change control.

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    1. 1
      Software & AI

      Software as a Medical Device(SaMD)

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

      Why this term here: The distinction that decides whether your app is itself a device.

    2. 2
      Software & AI

      Software in a Medical Device(SiMD)

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

      Why this term here: The other side: software embedded in or required by a hardware device.

    3. 3
      Standards

      IEC 62304

      Lifecycle requirements for medical device software.

      Why this term here: The lifecycle standard that shapes your SDLC deliverables.

    4. 4
      Software & AI

      Software Safety Classification

      IEC 62304 classes A, B, C reflecting potential harm from software failure.

      Why this term here: Class A / B / C: the single biggest driver of process rigor.

    5. 5
      Software & AI

      Software of Unknown Provenance(SOUP)

      Software not developed for medical device use, or lacking adequate development records, incorporated into a device.

      Why this term here: Software Of Unknown Provenance: how open-source dependencies get evaluated.

    6. 6
      Quality & Risk

      Verification & Validation(V&V)

      Confirming design outputs meet inputs (V) and that devices meet user needs (V).

      Why this term here: The MedTech meanings of V&V, which do not match engineering shorthand.

    7. 7
      Software & AI

      Clinical Decision Support(CDS)

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

      Why this term here: Clinical Decision Support: where the device / non-device line matters most for software.

    8. 8
      Cybersecurity

      Section 524B of the FD&C Act(524B)

      The federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices.

      Why this term here: The FD&C Act section that turned cybersecurity into a premarket must-have.

    9. 9
      Cybersecurity

      Secure Product Development Framework(SPDF)

      A documented, risk-based set of processes that build cybersecurity into a medical device across its full lifecycle.

      Why this term here: Secure Product Development Framework: the process 524B expects.

    10. 10
      Cybersecurity

      Software Bill of Materials(SBOM)

      A machine-readable inventory of all software components, including open-source and third-party libraries, used to build a medical device.

      Why this term here: Software Bill of Materials: now required in the eSTAR premarket package.

    11. 11
      Cybersecurity

      Threat Modeling

      A structured analysis that identifies how an attacker could compromise a medical device and what controls mitigate each threat.

      Why this term here: The design-time practice regulators expect to see documented, not just done.

    12. 12
      Software & AI

      Predetermined Change Control Plan(PCCP)

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

      Why this term here: How to ship model updates without a new submission each time.

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