UL Japan Official site

[Complete 6 Sessions Introductory Series Seminar] Session 3: Introduction to Testing and Evaluation Standards for Medical Devices – Cybersecurity

UL Japan

Overview of Medical Device Regulations and Key Points of Safety Testing and Evaluation! This is the third installment of a six-part online seminar that explains the overview of standards related to medical devices and key points of safety testing and evaluation. ---- Session 3: Introduction to Testing and Evaluation Standards for Medical Devices – Cybersecurity In 2021, IEC 81001-5-1, a lifecycle standard for ensuring the safety, effectiveness, and security of healthcare and health IT systems, including medical devices, was issued. Major regulatory authorities, including the International Medical Device Regulators Forum (IMDRF), began issuing guidance for addressing cybersecurity in medical devices. In this seminar, we will explain the overview and noteworthy requirements related to cybersecurity, focusing on IEC 81001-5-1, which medical device manufacturers should consider when addressing cybersecurity. This is an opportunity to deepen your understanding of cybersecurity, which is also gaining attention in regulatory frameworks in Japan, the United States, and Europe, through a comprehensive approach across the product lifecycle.