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.