Notice of Expansion of ISO13485 Registration Scope

2024.09.05

We would like to take this opportunity to thank you for your continued support.

As of August 10, 2024, the scope of registration for ISO13485 certification, the international standard for quality assurance of medical devices, has been expanded as follows.

Registered Office	Scope of registration
	Before expansion	After expansion
J-Sol Medical Co., Ltd.	Design, development and manufacture of catheter for temperature monitorring	Design, development and manufacture of catheter for temperature monitorring
J-Sol Medical Co., Ltd. Chiba Factory	－	Manunfacturer (boxing, labelling and storage) and EO sterilization of catheter for temperature monitoring

The newly registered Chiba Plant of J-SOL Medical has an integrated production system covering design, development, manufacturing, inspection, and storage, and is a plant that will further promote our one-stop solution services.

Together with the Tokyo Head Office Plant, we will continue to provide services that meet the needs of our customers, and we look forward to your continued support and patronage in the future.

There will be no change in the registration number and the registration organization.
Please click here for details.