Research on risk management of cybersecurity capabilities for active medical device products prior to marketing

• 1、Center for Drug Evaluation and Monitoring of Fujian, Fujian Province, Fuzhou, 350003
• 2、School of Informatics, Xiamen University Xiamen, Fujian 361005, China

Abstract：This article focuses on the core components and cybersecurity features of active medical device products, in accordance with the guidelines released by the National Medical Products Administration. This paper addresses the potential cybersecurity risks of the representative active medical devices such as electrocardiogram devices and remote monitoring equipment during the their medical services. This paper discusses the essence of cybersecurity capability requirements, and provides the practical risk control strategy recommendations. This research provides valuable experience references and technical supports for medical device companies to manage cybersecurity risks in product development and manufacturing. The study also makes important guides for the technical review of medical device registration prior to marketing.

Keywords： medical device cybernetic security risk management