During the Safety Critical Systems Symposium SSS’24 in Bristol, UK, our research paper within ITN Eternity titled ‘Ensuring Safety and Effectiveness of Medical Devices in the Presence of Electromagnetic Disturbances through Unified EMC Assurance: A Compliance Pattern’ was presented.
This recorded presentation primarily aims to address the following questions:
- What does ‘safe and effective medical device’ mean within the Medical Device Regulation 2017/745?
- What is ‘EMC for safety (IEC 60601-1-2)’ and EMC for performance (IEC/TR 60601-4-2)?
- What is the risk-resilience-compliance framework to maintain EMC through EMI risk management (ISO14971) and EM resilience (IEEE 1848)?
- What is the novel goal-based unified EMC assurance case approach using modular arguments towards extensive technical documentation?
- How do EMC compliance patterns separate complex concerns from higher-level regulations to lower-level standards?
- How can the developed patterns be used throughout the medical device design and development as an EMC process?
- How can the patterns be adapted to various country-wide regulations with slight modifications and to a broad range of medical devices?
ESR14 would like to acknowledge Mike Parsons, Alex King, and Brian Jepson from the Safety Critical System Club for recording this presentation and the European Union MSCA grant agreement for funding this research.
Additionally, ESR14 extends his gratitude to his supervisor, Davy Pissoort, and the remaining co-authors: Laure Buysse, Dries Vanoost, Johan Catrysse (KU Leuven Brugge), and Rob Kleihorst (Philips), for their valuable contributions.