--- title: "Model Card, Definition | MedTech Terms" description: "Structured documentation of a machine learning model's intended use, performance, and limitations. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Software & AI](/terms?cat=Software%20%26%20AI) 6. / 7. Model Card [All terms](/terms) Software & AI [AI / ML in Devices](/ecosystems/ai-ml)[Software Lifecycle](/ecosystems/software-lifecycle) # Model Card Structured documentation of a machine learning model's intended use, performance, and limitations. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition A model card summarizes a model's purpose, training and evaluation data, performance metrics across relevant subgroups, ethical considerations, and known limitations to support transparent, responsible use. What the regulation says Regulators increasingly expect transparency in AI/ML-enabled MedTech. The FDA ## What this means in practice Increasingly expected by regulators (e.g., FDA's transparency principles for ML-enabled devices) and procurement teams. Often combined with 'Indications-for-Use'-style cards for clinical AI. ## Examples - A MedTech company developing an AI diagnostic tool for radiology creates a model card detailing the training data's demographic representation and the model's sensitivity and specificity across different patient populations. - Before deploying an AI-powered insulin pump, the manufacturer publishes a model card outlining the algorithm's performance under various physiological conditions and known limitations, such as interaction with specific medications. - A hospital procurement team reviews the model card for an AI-driven surgical planning system to assess its suitability for their patient demographics and to understand its validation against relevant clinical endpoints. Common pitfalls - • Failing to update model cards when models are retrained or modified, leading to outdated or inaccurate information, is a common pitfall. - • Overlooking the inclusion of performance metrics for all relevant subgroups, which can mask biases or disparities, is a mistake to avoid. - • Presenting overly technical information without clear, concise summaries for diverse audiences can hinder effective communication. - • Ignoring the iterative nature of AI development and not treating the model card as a living document can lead to compliance issues. ## Frequently asked questions What is the primary purpose of a Model Card in MedTech? The primary purpose is to provide a structured, transparent summary of an AI/ML model's characteristics, performance, and limitations, facilitating responsible development and deployment in MedTech. How does a Model Card relate to regulatory submissions? Who is the audience for a Model Card? ## Cross-references ### Used by Things that build on this term. - [ AI/ML-Enabled Medical Device ](/terms/ai-ml-device) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Software & AI Good Machine Learning Practice(GMLP) Guiding principles for the development of AI/ML-enabled medical devices. ](/terms/good-machine-learning-practice)[ Software & AI AI/ML-Enabled Medical Device Medical device that uses artificial intelligence or machine learning to perform its intended use. ](/terms/ai-ml-device) ### AI/ML Devices Deep Dive · From this learning path [ Software & AI Model Drift Monitoring Ongoing surveillance of input data and model outputs to detect performance degradation post-deployment. Adjacent lesson ](/terms/drift-monitoring?from=ai-ml-devices-deep-dive)[ Software & AI Explainability and Interpretability Methods (SHAP, saliency maps, prototype explanations) that help users understand why a model made a given prediction. ](/terms/explainability?from=ai-ml-devices-deep-dive)[ Software & AI Foundation Model (Healthcare) Large pretrained model adaptable to many downstream clinical tasks via fine-tuning or prompting. ](/terms/foundation-model-health?from=ai-ml-devices-deep-dive)[ Software & AI Generative AI in Medical Devices Devices that use LLMs or diffusion models to generate text, images, or recommendations within a clinical workflow. ](/terms/generative-ai-devices?from=ai-ml-devices-deep-dive) ### More in Software & AI · Same category [ Software & AI Predetermined Change Control Plan(PCCP) FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices. ](/terms/ai-ml-pccp)[ Software & AI Software as a Medical Device(SaMD) Software intended for medical purposes that performs without being part of a hardware device. ](/terms/samd) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [AI/ML Devices Deep Dive](/paths/ai-ml-devices-deep-dive)Lesson 4 of 9 Ecosystems (2) - [AI / ML in Devices](/ecosystems/ai-ml) - [Software Lifecycle](/ecosystems/software-lifecycle) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 1. [1 FDA Transparency Principles for ML Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/software-medical-device-samd/transparency-machine-learning-enabled-medical-devices-guiding-principles) 2. [2 FDA - Software as a Medical Device (SaMD) Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd) 3. [3 FDA - AI/ML-Enabled Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building software-as-a-medical-device? We help SaMD and AI/ML device teams meet IEC 62304 and the FDA's evolving expectations for software cybersecurity. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Software & AI Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=model-card) Learn in 60 seconds Card Lesson Quiz Structured documentation of a machine learning model's intended use, performance, and limitations. - · Increasingly expected by regulators (e.g., FDA's transparency principles for ML-enabled devices) and procurement teams. - · Often combined with 'Indications-for-Use'-style cards for clinical AI. Remember this Watch out: Failing to update model cards when models are retrained or modified, leading to outdated or inaccurate information, is a common pitfall. Related terms - [AI/ML-Enabled Medical Device ](/terms/ai-ml-device) - [Good Machine Learning Practice(GMLP) ](/terms/good-machine-learning-practice) You may also need Auto-suggested from Software & AI and shared keywords. - [Algorithmic Bias and Fairness ](/terms/ai-bias-fairness) - [Datasheets for Datasets ](/terms/datasheets-for-datasets) - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) - [Algorithm Change Protocol(ACP) ](/terms/algorithm-change-protocol) - [Federated Learning ](/terms/federated-learning) - [MLOps for Medical Devices(MLOps) ](/terms/mlops-medical-device) [All Software & AI terms](/terms?cat=Software%20%26%20AI) From the Blue Goat network Related resources and services on this topic. - [ AI SaMD Insights How AI is changing SaMD - risk, regulation, and good machine-learning practice. ](https://ai-samd.com) - [ Med Device Cyber Podcast Conversations with medical device cybersecurity practitioners. ](https://mdcpodcast.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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