14971based

14971based is an informal descriptor used to indicate that a medical device, its development process, or its documentation adheres to the principles of ISO 14971, the international standard for risk management of medical devices. The term signals alignment with a structured framework for identifying hazards, assessing and controlling risks, and evaluating residual risk, though it is not a formal designation within the standard itself.

A 14971based approach typically involves creating and maintaining a risk management file that documents the entire risk management process. Key elements include hazard identification, risk analysis, risk evaluation, and the selection and verification of risk controls. The process requires justification of risk acceptability, documentation of residual risk, and a clear linkage between risk management activities and the device’s design, production, labeling, and post-market surveillance. The framework encourages traceability, ongoing monitoring, and updates in response to new information or changing conditions.

Scope and regulatory relevance vary by region but generally apply across the lifecycle of a medical device, from concept and design through manufacturing, deployment, and post-market activities. ISO 14971 is often used in conjunction with quality management systems such as ISO 13485, and many regulatory regimes recognize ISO 14971 as a foundational reference for risk management. While the term 14971based is not a compulsory label, it is commonly used to communicate that a product or process follows a systematic risk management approach grounded in ISO 14971.