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Software Team Onboarding

Name: Software Team Onboarding
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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

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

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

Standards

IEC 62304

Lifecycle requirements for medical device software.

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

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

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

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

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

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

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

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

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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Software Team Onboarding

Software as a Medical Device(SaMD)

Software in a Medical Device(SiMD)

IEC 62304

Software Safety Classification

Software of Unknown Provenance(SOUP)

Verification & Validation(V&V)

Clinical Decision Support(CDS)

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

Secure Product Development Framework(SPDF)

Software Bill of Materials(SBOM)

Threat Modeling

Predetermined Change Control Plan(PCCP)