With the release of the latest version of "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" by the US FDA in September 2023, and the update of "Guidelines for Industry on Management of Cybersecurity in Medical Device" by the Taiwan Ministry of Health and Welfare in 2021, addressing the requirements of cybersecurity has become a significant challenge for medical device manufacturers who have already implemented the IEC 62304 standard. The key to solving this challenge lies in the IEC 81001-5-1 standard, which builds upon IEC 62304 and incorporates requirements from IEC 62443-4-1 for Secure Software Development Lifecycle (SSDLC), serving as guidance for manufacturers to achieve secure software development practices. This presentation will share practical insights into the challenges that manufacturers may face when implementing software security development processes and emphasize the key considerations they should focus on.