All MedTech Terms
513 sourced definitions covering the regulatory, quality, software, and cybersecurity vocabulary of modern medical devices.
Showing 1–24 of 31
AAMI TIR45(TIR45)
AAMI Technical Information Report providing guidance on applying Agile software development practices within an IEC 62304-compliant medical device software lifecycle.
Adversarial Robustness
Resilience of an ML model to inputs deliberately crafted to cause misclassification.
AI/ML-Enabled Medical Device
Medical device that uses artificial intelligence or machine learning to perform its intended use.
Algorithm Change Protocol(ACP)
Historical FDA AI/ML change-control terminology, now reflected in the PCCP Modification Protocol.
Algorithmic Bias and Fairness
Systematic differences in model performance across demographic or clinical subgroups.
Clinical Decision Support(CDS)
Software providing healthcare professionals with knowledge and patient-specific information.
Data Governance (AI/ML)
Policies, controls, and documentation for the data used to train, tune, and validate medical AI models.
Datasheets for Datasets
Structured documentation describing a dataset's motivation, composition, collection process, preprocessing, uses, and maintenance, the dataset equivalent of a model card.
EU AI Act
EU regulation establishing risk-based requirements for AI systems, including most medical AI.
Explainability and Interpretability
Methods (SHAP, saliency maps, prototype explanations) that help users understand why a model made a given prediction.
Federated Learning
Training paradigm where model updates are computed on local data and aggregated centrally - raw data never leaves the site.
Foundation Model (Healthcare)
Large pretrained model adaptable to many downstream clinical tasks via fine-tuning or prompting.
Generative AI in Medical Devices
Devices that use LLMs or diffusion models to generate text, images, or recommendations within a clinical workflow.
Good Machine Learning Practice(GMLP)
Guiding principles for the development of AI/ML-enabled medical devices.
Interoperability
Ability of devices and systems to exchange and use information.
Locked vs. Adaptive Algorithm
Distinction between models whose behavior is fixed at release vs. those that continue learning.
Medical Device Data System(MDDS)
Software data-transfer, storage, format-conversion and display functions excluded from device status; qualifying hardware follows a separate FDA policy.
MLOps for Medical Devices(MLOps)
The set of practices and tooling for deploying, monitoring, retraining, and governing machine learning models in regulated medical device software environments.
Model Card
Structured documentation of a machine learning model's intended use, performance, and limitations.
Model Drift Monitoring
Ongoing surveillance of input data and model outputs to detect performance degradation post-deployment.
ONC HTI-1 / HTI-2
ONC certification rules adding transparency and risk-management requirements to certified health IT, including AI/predictive DSI.
Predetermined Change Control Plan(PCCP)
FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices.
Predetermined Maintenance vs PCCP
Distinction between routine maintenance changes (cybersecurity patches, minor fixes) and PCCP-controlled algorithm changes.
Secure-by-Design (Devices)
Engineering principle of building security in from initial architecture rather than bolting it on.