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QUALITY SYSTEM

Berkeley Advanced Biomaterials is ISO 13485 certified (BSI, UK) in the area of "Design, Development, Manufacture and Distribution of Bone Graft". The certification demonstrates that Berkeley Advanced Biomaterials has established and is maintaining a quality system that meets the requirements of ISO 13485. In addition, all research, product development and manufacturing activities are performed in compliance with current good manufacturing practice (cGMP). Berkeley Advanced Biomaterials manufacturing facilities are registered with the FDA and audited on a regular basis.

Download our BSI ISO certificate:

Quality Management System Certificate

Download our California Tissue Bank license.

Download our Florida Tissue Bank license.

Download our Maryland Tissue Bank license.

Download our New York Tissue Bank license.

Download our Illinois Tissue Bank license.

Download our 2013 FDA Establishment Registration for Tissue.


 
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