Ensuring Safety and Effectiveness of Medical Devices in the Presence of Electromagnetic Disturbances through Unified EMC Assurance: A Compliance Pattern

This paper introduces a novel approach to developing a compliance pattern for a unified EMC assurance case, ensuring the safety and effectiveness of medical devices. The Goal Structuring Notation is used as a graphical notation for the technical documentation to support the safety and effectiveness compliance. By adopting this approach, the limitations of conventional text-based methods are overcome by providing a clear and explicit visual summary of claims, arguments, and evidence. Through persuasive arguments, the compliance pattern of the unified EMC assurance case demonstrates the adherence to EMC standards after successful implementation of EMC risk management strategies, achieved through the utilisation of EM-resilience design practices. Moreover, the paper emphasises the inter-relationships among the three sub-cases (compliance case – risk case – confidence case), highlighting their collective significance. The proposed EMC compliance pattern employs the modular extension of the Goal Structuring Notation to link arguments from the risk and confidence cases to the compliance case. The culmination of these elements validates the assurance of compliance with basic safety, essential performance, and the intended use of medical devices in the presence of electromagnetic disturbances. By employing the graphical notation and assurance case methodology, this approach presents a comprehensive EMC process for tackling the unique challenges posed by electromagnetic disturbances. As such, this approach contributes to ensuring the re-liability and functionality of medical devices in such environments.