Medical Device EMC Testing Services

The technical standards targeting medical devices are complex and varied, including the IEC 60601-1 series and individual standards from the IEC 60601-2 series. Additionally, in recent years, revisions have been made to the EMC standards. In this webinar, as part of the introductory series on safety standards for medical devices in 2025, we will provide an overview of IEC 60601-1-2, explain electromagnetic interference testing, and discuss the changes from the 4th edition to the 4.1 edition. We will also introduce some testing methods for basic standards that were requested in last year's survey.

We will be holding our popular webinar series on the introduction to safety standards for medical devices again this year, enhancing the content as always. In its third year, this time we will add new themes and incorporate the latest information, providing clear explanations of the overview of standards related to medical devices, as well as safety testing and evaluation points. We encourage you to use this as internal training for those involved in development, regulatory affairs, and quality control at medical device manufacturers. This webinar serves as an introduction to the "Webinar Series on Understanding Safety Standards for Medical Devices from the Basics," where we will introduce the regulations and standards for testing and evaluation related to safety for medical devices in major countries. We will also delve into the standards concerning usability and cybersecurity that will be applicable in Japan in 2024. We hope this will help you understand and prepare the necessary items for testing and evaluation in advance, thereby reducing the burden of applications as much as possible.

The technical standards targeting medical devices are complex and varied, including the IEC 60601-1 series and individual standards from the IEC 60601-2 series. In recent years, revisions have been made to EMC standards, and the transition period to the JIS standard JIS T 0601-1-2:2023, issued in February 2023, is approaching in mid-February 2026. In this seminar, as part of the introductory series on safety standards for medical devices in 2024, we will not only provide an overview of IEC 60601-1-2 and an explanation of electromagnetic interference testing but also discuss the changes from the 4th edition to the 4.1 edition of IEC 60601-1-2 in line with JIS T 0601-1-2:2023. You can check the details of the seminar by clicking the "Details & Registration" button below.

An introductory seminar on safety standards for medical devices that will be useful to know! This is the 2024 revised edition of last year's highly acclaimed introductory series seminar. We will incorporate the latest information and clearly explain the overview of standards related to medical devices, as well as safety testing and evaluation points in a total of five online seminars. In this seminar, we will introduce the regulatory overview for medical devices in the United States, Europe, and Japan, as well as the standards for non-clinical trials and evaluations required for drug applications. You can check the details of the seminar by clicking the "Details & Registration" button below.