[Seminar/Training] Introduction to AI Systems in Medical Devices (AI in Medical Engineering)

Seminar on the overall picture and safety considerations of AI medical device design and development from inception to post-market, held on September 9.

AI (artificial intelligence) and machine learning (ML) are rapidly being utilized in the field of medical devices, expanding their 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 challenges in design, evaluation, and operation 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 a comprehensive understanding from development to post-market, acquiring foundational knowledge useful for practical applications.

• Technical Seminar

We would like to express our congratulations on the continued prosperity of your esteemed company. Our company will be exhibiting at the following trade show, where we will introduce a number of products, including new ones. We sincerely apologize for the inconvenience during your busy schedule, but we would like to invite you to attend this event. 【 Exhibition Name 】 31st Measurement and Measurement Exhibition INTERMEASURE 2024 Official Website: https://intermeasure.org/itms2024/ 【 Dates 】 From __ (Wednesday) to __ (Friday), 202_ 【 Venue 】 Tokyo Big Sight (Tokyo International Conference Center) East Hall (Booth Number: ___) 【 Exhibited Products 】 - Air Leak Tester - Hydrogen Leak Detector - Pin Hole (Reference Test Piece) and more. For more details, please refer to the "Related Materials" (PDF file) below.

[Lecturer] Director of the Next-Generation Intelligent Systems Research Center, The University of Tokyo / Professor, Graduate School of Information Science and Technology Program Director, Moonshot Research and Development Program Goal 3 Mr. Yasuo Kuniyoshi [Key Lecture Content] Amidst declining birth rates and an aging population, our country requires new intelligent systems that can support diverse workplaces while collaborating with people. The Moonshot Goal 3 aims to "realize robots that learn, act, and coexist with humans through the co-evolution of AI and robots by 2050," with a new project set to launch in the fiscal year 2026. In this lecture, I will introduce the overall picture of the project, discuss societal challenges and expectations for humanoid AI robots, and outline the vision for realizing humanoids that learn and grow while adapting to unknown environments, touching upon key technological areas such as "cognitive development" and "embodiment" in humanoid AI robots. [Lecture Items] 1. Societal challenges and expectations for humanoid AI robots 2. Direction of research and development to aim for 3. Key research and development items 4. Overview of Moonshot Goal 3 5. Introduction of main research content 6. Q&A / Business card exchange

[Speaker] Yoichiro Ide, Senior Manager, CCaSS Division, EY ShinNihon LLC [Key Lecture Content] In the EU, efforts to accelerate the transition to a circular economy (CE) are rapidly advancing with the establishment of regulations such as the European Battery Regulation (EUBR), the Packaging and Packaging Waste Regulation (PPWR), and the Digital Product Passport (DPP). These are not merely environmental regulations but are positioned as a policy package that redesigns market rules and creates new demand and competitive environments. This lecture will interpret the market structure envisioned by the EU circular economy policy, explain the latest trends and practical responses regarding EUBR, PPWR, and DPP, and introduce the perspectives required for Japanese companies in terms of response and strategy formulation. [Lecture Items] 1. Market structure envisioned by the EU circular economy policy 2. Practical responses to the European Battery Regulation (EUBR) 3. Practical responses to the Packaging and Packaging Waste Regulation (PPWR) 4. Latest trends and practical response tips for the Digital Product Passport (DPP) 5. Perspectives for strategy formulation towards circular transition 6. Q&A / Business card exchange

[Instructor] Takahisa Saito, Certified Social Insurance Labor Consultant, Saito Social Insurance Labor Consultant Office [Key Lecture Content] Inspections by the Labor Standards Inspection Office can occur suddenly one day. Corporations do not have the authority to refuse them. This is called an inspection. If legal violations are clearly identified during the inspection, a corrective recommendation will be issued. It is important to know in advance how to respond before or after such a situation arises. Additionally, the ongoing work style reforms are influencing inspections by the Labor Standards Inspection Office. The number of inspections, which had decreased during the COVID-19 pandemic, is now on the rise. In this seminar, we will provide a clear explanation of the overview of inspections and the preparation of reports in response to corrective recommendations, based on the enforcement of revised labor standards laws, while sharing anticipated information. Furthermore, attending in person allows for meaningful information exchange through questions and mutual confirmation. [Lecture Topics] 1. Labor Standards Inspection Office and Labor Standards Inspectors 2. Overview of Inspections 3. Preparation for Inspections (Before the Inspector Arrives) 4. Response on the Day of Inspection to Reporting 5. Issues to Consider During Inspections 6. Recent Trends 7. Q&A / Business Card Exchange

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