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 Sponsors International Research Seminar

Fibralign Sponsors International Research Seminar

Fibralign is hosting the inaugural Lymphedema Summit on January 23-   Fibralign is hosting the inaugural Lymphedema Summit on January 23, an international research seminar focused on “Advancements in Lymphedema Surgical Treatment.” For more details:...

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Fibralign Selected as a UCSF Rosenman Institute Innovator

Fibralign Selected as a UCSF Rosenman Institute Innovator

NCI-funded study evaluating Fibralign’s BioBridge® as an adjunct to microsurgical treatment SAN FRANCISCO, June 10, 2021 /PRNewswire/ -- The UCSF Rosenman Institute is proud to announce the 2021 cohort of the Rosenman Innovators, a group of early-stage health...

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