Medical device product safety standards evaluation, testing, and certification 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.

We will hold an online free technical consultation session regarding medical device safety standards (60601/61010). - "I want to confirm whether the design of the medical device under development complies with the applicable standards." - "I want to check the applicable standards for the medical device under development before requesting an evaluation." - "I want to know the latest status of the 61010-1 standard and individual standards (e.g., EN IEC 61010-2-101:2022/A11:2022, etc.)." - "I want to confirm the available services, estimated costs, required time, necessary documents/samples, and key points for component selection." - "I would like to take this opportunity to ask questions about the requirements of the 61010-1/60601-1 standards." This is recommended for medical device manufacturers who have such questions or challenges. The application deadline is until July 31, so please take advantage of this opportunity. You can check the details of the seminar by clicking the "Details & Application" button below.

ISO 18562 requires testing and evaluation of particulate matter, volatile organic solvents, and condensation that occurs in medical devices with respiratory gas pathways, playing a crucial role in ensuring safe use. This seminar will provide a simple introduction to the testing and evaluation content of ISO 18562. It will be beneficial not only for manufacturers of medical devices that already have respiratory gas pathways but also for those planning to develop such devices in the future. Additionally, there was a revision of the ISO 18562 standard in March of this year, and we will also introduce the key points of that revision. You can check the details of the seminar by clicking the "Details & Registration" button below.