Fibralign receives ISO 13485:2016 upgrade certification

Jan 12, 2019

Fibralign received Certification Notification on January 21, 2019 from DEKRA Certification B. V. that the Company’s management system meets the requirements of EN ISO 13486:2016. This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry. 

ISO 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations. The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.

Fibralign has developed and established an end-to-end manufacturing system for production of its BioBridge Collagen Matrix in its GMP facility located in Union City, California.

Fibralign Announces CE Mark Approval for BioBridge®

Fibralign Announces CE Mark Approval for BioBridge®

European approval for novel device supporting surgical treatment of lymphedema September 14, 2020 (Union City, CA) – Fibralign Corp., a Stanford spin-out and developer of therapeutic biomedical devices, today announced that it has received CE mark for its first...

read more
Fibralign Announces Strategic Partnership with Terumo

Fibralign Announces Strategic Partnership with Terumo

Exclusive agreement for Terumo to market and distribute Fibralign’s BioBridge in Japan June 02, 2020 06:00 AM Eastern Daylight Time UNION CITY, Calif.--(BUSINESS WIRE)--Fibralign Corp., a Stanford spin-out developer of therapeutic biomedical devices, has announced...

read more
Fibralign Awarded SBIR Phase IIS from Department of Defense

Fibralign Awarded SBIR Phase IIS from Department of Defense

Fibralign announced today that it has been awarded a Small Business Innovation Research (SBIR) Sequential Phase II (Phase IIS) from the Department of Defense (DoD) Defense Health Program (DHP). This two-year grant provides $996,609 in funding to continue advancing...

read more