Certified Japan's first ISO-13485 for decellularized tissue for regenerative medical device and medicine
Oct. 07, 2019
ADEKA Corporation announced that certification ISO-13485:2016, an international quality management system for medical devices has issued to us as Japan's first decellularized tissue materials※ for medical implant.
We will commit to accelerate for the development through co-developments with medical advisory board and/or prototype distribution to the ones who have its interest for the decellularized tissue as a surgical material.
In order for medical field's contribution, since 2013, we, ADEKA has been working on the developments for decellularized technologies used by xenograft, animal origin which enables acellular scaffolds for safety and quality human use.
Based on the long historical development background for chemicals and foods, we, ADEKA will continue and accelerate for this decellularized technology by animal origin aiming for medical market penetration.
◆Outline of ISO Certification
Applied Standards |
ISO 13485:2016 |
|---|---|
Certificate No |
Q5 101475 0001 Rev. 00 |
Date |
August 7, 2019 |
Facilities |
ADEKA Corporation, Arakawa Tokyo and ADEKA Corporation Kashima Plant-West, Kamisu-shi, Ibaraki |
Scope of Certificate |
Design and Development, Production and Distribution of Decellularized Animal Tissue Materials Utilized for Surgical Medical Devices |
Certified Body |
TÜV SÜD Prroduct Service GmbH |
※1 About Decellularized Tissues for Medical use：
Allograft or xenograft tissue from animal origin such as bovine or porcine with decellularized treatment by physically and/or chemically procedures for transplant (Extra Cellular Matrix: ECM) They are implementing in the clinical field in the overseas. We are aiming to develop safe and less rejection scaffolds.
■ Contacts
ADEKA Corporation
Publicity & Administration group, Legal Affairs ＆ Publicity Department
TEL：+81-3-4455-2803