テュフズードジャパン Product Lineup

This document is a white paper that examines the EU AI Act, a comprehensive legal framework regarding AI, from the perspective of its application to the medical device industry. It explains important aspects such as the impact of the EU AI Act on the medical device industry, prohibited uses of AI, risk-based classification, and obligations for transparency. In addition to discussing the relationship between the EU AI Act and the European Medical Device Regulation (EU MDR) and ensuring compliance, it also introduces the concept of a regulatory sandbox. 【Contents】 ■ Introduction ■ Important aspects of the EU AI Act concerning medical devices ■ Inconsistencies between the EU AI Act and EU MDR requirements ■ Ensuring compliance with the EU AI Act and EU MDR ■ Regulatory sandbox ■ Conclusion *For more details, please download the PDF or feel free to contact us.

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.