---
title: "AI / ML in Devices - MedTech Ecosystems"
description: "Everything specific to AI/ML-enabled medical devices - predetermined change control plans, model cards, the EU AI Act, ISO/IEC 23894, and the data-and-bias…"
lang: en
json-ld:
---

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Ecosystem 

# AI / ML in Devices

Everything specific to AI/ML-enabled medical devices - predetermined change control plans, model cards, the EU AI Act, ISO/IEC 23894, and the data-and-bias practices that regulators now expect.

40 terms

## Regulatory11 

-   [AI Act Conformity Assessment (Medical Devices) ](/terms/ai-act-conformity-assessment)
-   [AI Act Post-Market Monitoring ](/terms/ai-act-post-market-monitoring)
-   [AI Act Prohibited Practices ](/terms/ai-act-prohibited-practices)
-   [AI Act Serious Incident Reporting ](/terms/ai-act-serious-incident-reporting)
-   [AI Act Technical Documentation (Annex IV) ](/terms/ai-act-technical-documentation)
-   [AI Act Transparency Obligations ](/terms/ai-act-transparency-obligations)
-   [Fundamental Rights Impact Assessment(FRIA) ](/terms/ai-act-fria)
-   [General-Purpose AI Model(GPAI) ](/terms/ai-act-gpai)
-   [High-Risk AI System (EU AI Act) ](/terms/ai-act-high-risk-system)
-   [Provider and Deployer (EU AI Act) ](/terms/ai-act-provider-deployer)
-   [Systemic Risk (GPAI) ](/terms/ai-act-systemic-risk)

## Cybersecurity5 

-   [LINDDUN ](/terms/linddun)
-   [MITRE ATT&CK(ATT&CK) ](/terms/mitre-attack)
-   [STRIDE Threat Model(STRIDE) ](/terms/stride)
-   [Threat Modeling ](/terms/threat-modeling)
-   [Zero Trust Architecture(ZTA) ](/terms/zero-trust)

## Standards1 

-   [ISO/IEC 23894 ](/terms/iso-iec-23894)

## Software & AI20 

-   [Adversarial Robustness ](/terms/adversarial-robustness)
-   [AI/ML-Enabled Medical Device ](/terms/ai-ml-device)
-   [Algorithm Change Protocol(ACP) ](/terms/algorithm-change-protocol)
-   [Algorithmic Bias and Fairness ](/terms/ai-bias-fairness)
-   [Data Governance (AI/ML) ](/terms/data-governance)
-   [Datasheets for Datasets ](/terms/datasheets-for-datasets)
-   [EU AI Act ](/terms/eu-ai-act)
-   [Explainability and Interpretability ](/terms/explainability)
-   [Federated Learning ](/terms/federated-learning)
-   [Foundation Model (Healthcare) ](/terms/foundation-model-health)
-   [Generative AI in Medical Devices ](/terms/generative-ai-devices)
-   [Good Machine Learning Practice(GMLP) ](/terms/good-machine-learning-practice)
-   [Locked vs. Adaptive Algorithm ](/terms/locked-vs-adaptive)
-   [MLOps for Medical Devices(MLOps) ](/terms/mlops-medical-device)
-   [Model Card ](/terms/model-card)
-   [Model Drift Monitoring ](/terms/drift-monitoring)
-   [ONC HTI-1 / HTI-2 ](/terms/onc-hti)
-   [Predetermined Change Control Plan(PCCP) ](/terms/ai-ml-pccp)
-   [Predetermined Maintenance vs PCCP ](/terms/predetermined-maintenance)
-   [Synthetic Data ](/terms/synthetic-data)

## Market Segments1 

-   [AI Imaging Software ](/terms/ai-imaging)

## Reimbursement1 

-   [Budget Impact Model(BIM) ](/terms/budget-impact-model)

## Commercialization1 

-   [Razor / Razor-Blade Model ](/terms/razor-razorblade)

### Other ecosystems

[Regulated Pathways](/ecosystems/regulated-pathways)[Connected & Cyber-Physical Devices](/ecosystems/connected-devices)[Software Lifecycle](/ecosystems/software-lifecycle)[Quality System](/ecosystems/quality-system)[Clinical Evidence](/ecosystems/clinical-evidence)[Post-Market & Safety](/ecosystems/post-market-safety)[Global Markets](/ecosystems/global-markets)[Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer)[Startup Lifecycle](/ecosystems/startup-lifecycle)[Strategic Landscape](/ecosystems/strategic-landscape)[Manufacturing & Supply](/ecosystems/manufacturing-supply)

MedTech Terms 

An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices.

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Resources

-   [FDA Medical Devices](https://www.fda.gov/medical-devices)
-   [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj)
-   [IMDRF](https://www.imdrf.org/)
-   [Methodology](/methodology)
-   [Changelog](/changelog)
-   [Editor: Christian Espinosa](/authors/christian-espinosa)
-   [About this site](/about)

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