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AI/ML Devices Deep Dive

Name: AI/ML Devices Deep Dive
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For teams shipping AI-enabled devices: PCCP mechanics, GMLP, model documentation, drift monitoring, and generative-AI considerations.

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0 of 9 lessons complete · up next: AI/ML-Enabled Medical Device

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1

Software & AI

AI/ML-Enabled Medical Device

Medical device that uses artificial intelligence or machine learning to perform its intended use.

Why this term here: The FDA definition that scopes what an 'AI-enabled device' actually is.
2

Software & AI

Predetermined Change Control Plan(PCCP)

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

Why this term here: Pre-Determined Change Control Plan: pre-authorize model updates in the submission.
3

Software & AI

Good Machine Learning Practice(GMLP)

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

Why this term here: The FDA / MHRA / Health Canada joint principles for ML lifecycle.
4

Software & AI

Model Card

Structured documentation of a machine learning model's intended use, performance, and limitations.

Why this term here: The transparency artifact that pairs a model with its intended use and limits.
5

Software & AI

Model Drift Monitoring

Ongoing surveillance of input data and model outputs to detect performance degradation post-deployment.

Why this term here: How to detect that a deployed model no longer performs as claimed.
6

Software & AI

Explainability and Interpretability

Methods (SHAP, saliency maps, prototype explanations) that help users understand why a model made a given prediction.

Why this term here: The XAI requirements that increasingly show up in premarket questions.
7

Software & AI

Generative AI in Medical Devices

Devices that use LLMs or diffusion models to generate text, images, or recommendations within a clinical workflow.

Why this term here: The emerging category where PCCP alone is not yet sufficient.
8

Software & AI

Foundation Model (Healthcare)

Large pretrained model adaptable to many downstream clinical tasks via fine-tuning or prompting.

Why this term here: How large pretrained models change the risk conversation.
9

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: Almost every AI/ML device is SaMD; know why that framing matters.

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AI/ML Devices Deep Dive

AI/ML-Enabled Medical Device

Predetermined Change Control Plan(PCCP)

Good Machine Learning Practice(GMLP)

Model Card

Model Drift Monitoring

Explainability and Interpretability

Generative AI in Medical Devices

Foundation Model (Healthcare)

Software as a Medical Device(SaMD)