「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(effective date:August 9, 2027)
Certified For	ISO13485:2016
Registered Activities	Design, development, manufacture and EO sterilization of catheter for temperature monitorring
Scope of registration for registered establishments and each establishment	J-Sol Medical Co., Ltd. 2-5-16 Shimo-Ochiai, Shinjuku-ku, Tokyo, Japan Registration Scope: Design, development and manufacture of catheter for temperature monitorring
	J-Sol Medical Co., Ltd. Chiba Factory 193-27 Azasakuradai, Oseki, Yachimata-shi, Chiba, Japan Registration Scope: Manunfacturer (boxing, labelling and storage) and EO sterilization of catheter for temperature monitoring
Registered Number	MD 753741
Certified By	BSI Group Japan K.K.

The scope of registration of the Chiba Plant (EO sterilization and storage) was expanded as of August 10, 2024.

Certification Mark

Our ISO13485 Certification

*Unauthorized use of certification marks and certificates of registration is prohibited.