テュフズードジャパン Company Overview

AI (Artificial Intelligence) and Machine Learning (ML) are rapidly being utilized in the field of medical devices, expanding applications in various areas such as diagnostic support and image analysis. On the other hand, the development and market introduction of medical devices equipped with AI systems present design, evaluation, and operational challenges that differ from traditional medical devices. In this seminar, we will clearly explain the overall picture and basic concepts of AI medical devices, focusing on safety aspects. Participants will gain foundational knowledge useful for practical work by taking a comprehensive view from development to post-market. <Seminar Topics> - What is Machine Learning - Important considerations regarding the regulation of AI systems [CS3.1] - Risk management and corrective and preventive actions (CAPA) for AI systems - GMLP – Lifecycle of AI/ML-equipped medical devices

In this seminar, we will explain the overview and impact of the Cyber Security Act, NIS2 Directive, and Cyber Resilience Act, which are expected to affect domestic companies among various regulations. Given the complex interrelation of these laws, we will minimize the details as much as possible and focus on the key points that are important for manufacturers and the essential aspects that need to be understood. We will place particular emphasis on important parts for suppliers in the supply chain (such as scope of application and mandatory requirements) as we proceed with the explanation. <Seminar Topics> - Trends in cybersecurity standards and regulations in the industry - Key points of the EU Cyber Security Act - Key points of the EU NIS2 Directive - Key points of the EU Cyber Resilience Act - Relationship between the Cyber Resilience Act and IEC 62443 - Schedule of security regulations from the perspective of manufacturers