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SaMD & AI/ML Devices

Name: SaMD & AI/ML Devices
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From SaMD basics to PCCPs and Good Machine Learning Practice for AI-enabled devices.

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0 of 9 lessons complete · up next: Software as a Medical Device

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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 regulatory category for standalone software. Focus on the IMDRF framing and when software is a device at all.
2

Software & AI

Software in a Medical Device(SiMD)

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

Why this term here: Software inside a hardware device. Focus on how SiMD changes your risk analysis and lifecycle scope versus SaMD.
3

Standards

IEC 62304

Lifecycle requirements for medical device software.

Why this term here: The software lifecycle standard regulators expect. Focus on the process artifacts, not just the class assignment.
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 drives how much process rigor applies. Focus on how you justify the class in the risk file.
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: Third-party software you did not develop. Focus on the evidence you need to keep and the update cadence.
6

Software & AI

Clinical Decision Support(CDS)

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

Why this term here: Clinical Decision Support. Focus on the four-factor test that determines whether CDS is a device.
7

Software & AI

Predetermined Change Control Plan(PCCP)

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

Why this term here: The mechanism to update a model without a new submission. Focus on what belongs in the plan and what does not.
8

Software & AI

Good Machine Learning Practice(GMLP)

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

Why this term here: FDA/Health Canada/MHRA principles for AI/ML devices. Focus on the principles most examined in submissions.
9

Software & AI

Interoperability

Ability of devices and systems to exchange and use information.

Why this term here: How your software plays with EHRs and other devices. Focus on FDA's interoperability guidance and IEEE 11073.

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SaMD & AI/ML Devices

Software as a Medical Device(SaMD)

Software in a Medical Device(SiMD)

IEC 62304

Software Safety Classification

Software of Unknown Provenance(SOUP)

Clinical Decision Support(CDS)

Predetermined Change Control Plan(PCCP)

Good Machine Learning Practice(GMLP)

Interoperability