All pathsData · ML · RA · 9 terms

AI/ML Devices Deep Dive

Name: AI/ML Devices Deep Dive
Availability: InStock

For teams shipping AI-enabled devices: PCCP mechanics, GMLP, model documentation, drift monitoring, and generative-AI considerations.

Your progress

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

Start path

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.

Finished the path? Test yourself with a quiz tailored to these 9 terms.

Take the AI/ML Devices Deep Dive quiz

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)