July 2020 - TDK Corporation (TSE 6762) is pleased to announce that TDK-Lambda Japan received ISO 13485:2016 Medical Devices - Quality Management System - certification for the TDK-Lambda Nagaoka Technical Center (Nagaoka City, Niigata Prefecture, Japan). This is the first time a standard switching power supply manufacturer in Japan has received ISO 13485 certification and brings the group total to five locations.
The scope of this latest registration covers the Design/Development, Manufacturing and Servicing Activities (Analysis, Repair and Overhaul for Field Returns) of Components (Switching Power Supply) for Active Medical Devices. Now, five of TDK-Lambda’s major development, design and production sites in Japan, the United Kingdom, the United States of America, China, and Malaysia have been certified. This enhances the Group’s capability to provide products and services to the global medical device market.
TDK-Lambda has focused on the medical device market, developing a large portfolio of medically certified products to the international IEC 60601-1 standard. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities. It demonstrates a commitment to the safety and quality of medical devices.
More information about TDK-Lambda power supplies can be obtained from the TDK-Lambda Americas website at www.us.lambda.tdk.com.
About TDK Corporation
TDK Corporation is a world leader in electronic solutions for the smart society based in Tokyo, Japan. Built on a foundation of material sciences mastery, TDK welcomes societal transformation by resolutely remaining at the forefront of technological evolution and deliberately “Attracting Tomorrow.” It was established in 1935 to commercialize ferrite, a key material in electronic and magnetic products.
TDK's comprehensive, innovation-driven portfolio features passive components such as ceramic, aluminum electrolytic and film capacitors, as well as magnetics, high-frequency, and piezo and protection devices. The product spectrum also includes sensors and sensor systems such as temperature and pressure, magnetic, and MEMS sensors. In addition, TDK provides power supplies and energy devices, magnetic heads and more. These products are marketed under the product brands TDK, EPCOS, InvenSense, Micronas, Tronics and TDK-Lambda. TDK focuses on demanding markets in automotive, industrial and consumer electronics, and information and communication technology. The company has a network of design and manufacturing locations and sales offices in Asia, Europe, and in North and South America. In fiscal 2020, TDK posted total sales of USD 12.5 billion and employed about 107,000 people worldwide.
About TDK-Lambda Corporation
TDK-Lambda Corporation is a trusted, innovative leader and global supplier of highly reliable power conversion products for industrial and medical equipment worldwide.
TDK-Lambda Corporation is aligned for fast responses to any customer need with R&D, manufacturing, sales and service locations in five key geographic regions, namely Japan, EMEA, Americas, China and ASEAN.
For more details, please pay a visit to: www.jp.lambda.tdk.com/en/
Contact for media
Contact: Tom Tillman, TDK-Lambda Americas
Phone: (619) 575 4400