Fibralign receives ISO 13485:2012 Certification

Feb 17, 2018

Fibralign received Certification Notification on February 18, 2018 from notifying body DEKRA Certification B. V. that it’s management system meets the requirements of EN ISO 13486:2016:2012 + AC:2012.

The scope of the certification is for the design, development, manufacture and distribution of porcine collagen scaffold implants used for soft tissue repair and support, nerve repair, wound/scar management, orthopedics, vascular, ophthalmic and lymphatic therapeutic areas.

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...

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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...

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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...

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