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Five major TDK-Lambda Group sites have obtained certifications of ISO13485 quality management system for medical devices

Posted by Martin on June 26, 2020
Posted in: News
Nagaoka Technical Center

First acquisition of a standard switching power supply manufacturer in Japan

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 Medical devices 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 and Overhaul for Field Returns) of Components (Switching Power Supply) for Active Medical Devices.

TDK-Lambda has been focusing on the medical device market and actively working to acquire ISO13485 certification throughout the Group. Now, 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 will leverage the Group’s capability to provide products and services that can be adopted with higher confidence in the global medical device market.

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*1 Terms: 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 to address the Medical Device Directives, regulations, and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

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