[Seminar] Program Medical Devices (SaMD): Challenges of Utilizing Generative AI

basic information

**Lecture Overview** This presentation will outline the administrative efforts regarding software as a medical device (SaMD) and discuss the challenges and directions for addressing them, taking into account the introduction of the latest technologies. In particular, it will organize the issues related to risk assessment, plasticity, and black-box characteristics in SaMD utilizing generative AI, and introduce the framework established to address these issues, such as the two-tier approval system, the IDATEN framework enabling continuous improvement, support for startups, and the development of evaluation indicators for home-use SaMD, all aimed at early practical application. Furthermore, it will touch upon cybersecurity measures, prospects for the use of real-world data (RWD), and trends in international harmonization, discussing the challenges and future directions for the social implementation of SaMD. **Lecture Items** ■ Overview of Software as a Medical Device ■ Initiatives for DASH for SaMD2 ■ Regulatory Affairs for AI-utilizing SaMD ■ Cybersecurity Measures ■ Towards Smooth Social Implementation ■ Related Q&A ■ Business Card and Information Exchange Meeting

Price information

【Course Fee】 1 person: 37,990 yen (tax included) Special offer: One additional person from the same organization can attend for free (registration required) *For those affiliated with local public organizations, up to two people can attend for 11,000 yen (tax included / venue and live streaming only) *Those attending in person or via live streaming can add archive streaming for a special price of 18,500 yen (tax included).

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