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June 6, 2007

TOTOKU obtains Certification of ISO13485:2003, Medical Device Regulations

Tokyo, Japan – May 29, 2007- TOTOKU ELECTRIC CO., LTD. received a certificate of ISO13485, a quality management standard for medical devices.
In order to provide you with the highest quality of products and service, we will keep focusing on company wide quality management.

 
Certified Management System
・ISO 9001, JIS Q 9001
・ISO13485


Certificate

Applied Standard:  ISO13485: 2003      
Certification body: Tüv Rheinland Japan      
Date: May 29, 2007      
Certificate Number: SY 50107623 0001      
Scope of Certificate: Design, development, manufacturing, and servicing of medical image display system (for use in modalities and PACS)      

 

Overview

While we have achieved approval of ISO 9001 in 1994, which is a generic standard for quality management systems, and we have been making best efforts to provide high-quality products, medical displays used in viewing medical images for diagnosis are now in high demand, and their production, sales, and service are increasing.

TOTOKU assures that establishing and implementing the quality assurance system in accordance with ISO13485 that is a quality management standard for medical devices specifically will further provide reliable products for medical institutions.

About TOTOKU

TOTOKU, founded in 1940 and headquartered in Tokyo, Japan, is a leading manufacturer of high-end medical image displays and touch panels. Since its launch on the display business in 1968, TOTOKU has supplied displays for various fields and has earned high marks for its product reliability under harsh conditions and post installation support, not to mention specialized technologies that are required for the respective fields. TOTOKU’s products and services are available via the US, EU, and Asia offices and distributors throughout the world.

Contact

USA TOTOKU NORTH AMERICA, INC., in USA TEL: +1-469-442-0112
EUROPE TOTOKU ELECTRIC CO., LTD. in Germany TEL: +49-2156-4918-0
ASIA TOTOKU ELECTRIC CO., LTD. in Japan TEL: +81-3-5273-2053

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