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

Area of Science:

• Medical Device Engineering
• Systems Engineering
• Risk Management

Background:

• Risk management (RM) is crucial for medical device (MD) safety and regulatory compliance.
• Model-based systems engineering (MBSE) offers advanced tools for complex MD development.
• Integrating RM into MBSE can improve safety and efficiency.

Purpose of the Study:

• To integrate ISO 14971 risk management principles into an MBSE-driven medical device development process.
• To propose a framework for early-stage RM and safety analysis in MD development.
• To adapt OMG RAAML for the medical domain according to ISO 14971.

Main Methods:

• Developed a framework to model RM concepts within MBSE.
• Extended OMG RAAML for medical device RM and safety analysis.
• Applied the framework to an e-Glass system for EEG-based stress monitoring.

Main Results:

• Demonstrated the integration of ISO 14971 RM into MBSE for MD development.
• Enabled early-stage RM and safety analysis.
• Successfully applied the framework in a case study.

Conclusions:

• The proposed method and framework facilitate semi-automated RM based on ISO 14971.
• This approach aids in obtaining safer medical devices by design.
• It streamlines the medical device certification process.