Nissha Obtains ISO 13485 (Quality Management System for Medical Devices) Certification
for Global Headquarters in Kyoto

November 14, 2019

Nissha Co., Ltd.

Nissha Co., Ltd. (hereinafter, Nissha) obtained ISO 13485:2016 certification for its Global Headquarters in Kyoto as of October 29, 2019. ISO 13485 is the international standard for quality management systems covering medical devices. Following Nissha Group bases in North and Central Americas and Europe, the Global Headquarters in Kyoto is the ninth base to obtain certification.

Nissha made full-scale entry into the medical devices field with the establishment of the Medical Technologies Business Unit in 2016.
The business unit has strengthened business activities in primary markets in the Americas and Europe, while working to accelerate business expansion in the Asian region including Japan. To this end, in Japan it obtained a Second-class marketing license for medical devices in 2017, and started sales of medical devices in 2018.
With ISO 13485 certification of the Global Headquarters in Kyoto, Nissha plans to drive further growth in medical devices, one of its priority markets.

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- "Nissha" is a generic name of Nissha Co., Ltd. and "Nissha Group" is a Nissha Co., Ltd. and its group companies.

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