Power Supplies
Five major TDK-Lambda Group sites have obtained
certifications of ISO13485 quality management system for
medical devices
 First acquisition of a standard switching power supply manufacturer in Japan

June 17, 2020
TDK Corporation is pleased to announce that its subsidiary company, TDK-Lambda
Corporation (President: Hiroyuki Yashiro, hereafter TDK-Lambda) Nagaoka Technical Center(Nagaoka City, Niigata Prefecture), received a certification of ISO13485: 2016*1 Medicaldevices quality management systems for its quality management system. It is the first among
the standard switching power supply manufacturers in Japan.
Scope of Registration:
The Design/Development, Manufacturing and Servicing Activities (Analysis, Repair andOverhaul for Field Returns) of Components (Switching Power Supply) for Active MedicalDevices.
TDK-Lambda has been focusing on the medical device market and actively working toacquire ISO13485 certification throughout the Group. Now, TDK-Lambda’s major
development design and production sites in Japan, the United Kingdom, the United States ofAmerica, China, and Malaysia have been certified. This will leverage the Group’s capabilityto provide products and services that can be adopted with higher confidence in the global
medical device market.
----Terms*1 ISO13485

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory
purposes, is an internationally recognized standard for quality management systems for
medical devices. Adopting ISO 13485 provides a practical foundation for manufacturers toaddress the Medical Device Directives, regulations, and responsibilities as well as
demonstrating a commitment to the safety and quality of medical devices.
-----

TDK Corporation

1/ 2

About TDK Corporation

TDK Corporation is a world leader in electronic solutions for the smart society based inTokyo, Japan. Built on a foundation of material sciences mastery, TDK welcomes societal
transformation by resolutely remaining at the forefront of technological evolution anddeliberately “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 andpressure, magnetic, and MEMS sensors. In addition, TDK provides power supplies andenergy devices, magnetic heads and more. These products are marketed under the productbrands TDK, EPCOS, InvenSense, Micronas, Tronics and TDK-Lambda. TDK focuses on
demanding markets in automotive, industrial and consumer electronics, and information andcommunication technology. The company has a network of design and manufacturinglocations 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/----Contacts for regional mediaRegionJapanContactMr. Yoichi OSUGATDK Corporation

TDK Corporation
Tokyo, Japan

Phone

Mail+813 6778-1055

pr@jp.tdk.com

2/ 2