Model-Based ISO 14971 Risk Management of EEG-Based Medical Devices

Abstract

Risk management (RM) is a key component of the development of modern medical devices (MD) to achieve acceptable functional safety and pass the regulatory process. The emerging availability of various techniques, languages, and tools that use model-based system engineering (MBSE) promises to facilitate the development and analysis of complex MD. In this paper, we show how to integrate RM principles and activities recommended in ISO 14971 medical standard into an MBSE-driven MD development process. We propose a method and framework capable of modeling essential RM concepts and performing RM and safety analysis in the early stages of the MD development life cycle. The framework extends OMG RAAML (Object Management Group Risk Analysis and Assessment Modeling Language) to the medical domain according to ISO 14971. We illustrate our approach using a case study of the e-Glass system developed for real-time EEG-based subject monitoring with the intended use of stress monitoring.Clinical Relevance-This facilitates the MD certification process by semi-automation of RM based on ISO 14971 and obtaining safe MD by design.