Berkeley Advanced Biomaterials, Inc. 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, Inc. 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, Inc. manufacturing facilities are registered with the FDA and audited on a regular basis.

Download our BSI ISO certificates:

Quality Management System Certificate

Design Examination Certificate

Full Quality Assurance Certificate