「ISO13485」Certified

HOME > 「ISO13485」Certified

「ISO13485」Certified

We are now ISO13485, a quality management standard for medical device, certified.

Our intention to expand our business in imports, production, and design of medical device led us review our quality management system. As we are pushing ourselves to look into a possibility of new business such as exports of our own products, we have acquired ISO13485, an international quality management standard for medical device, in August, 2018.

 

Registered Date August 10, 2018
Certified For ISO13485:2016
Registered Location J-Sol Medical Co., Ltd.
2-5-16 Shimo-Ochiai, Shinjuku-ku, Tokyo, Japan
Registered Activities Design, develop, and manufacturing of Catheters
Registered Number MD 753741
Certified By BSI Group Japan K.K.

Notified body was moved from LRQA to BSI on Nov. 12, 2021.

Certification Mark

Our ISO13485 Certification

*Click here to see the PDF

Pagetop