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 receives ISO 13485:2012 Certification

Fibralign receives ISO 13485:2012 Certification

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,...

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AngelMD Closes Syndicate Funding Round in Fibralign

AngelMD Closes Syndicate Funding Round in Fibralign

AngelMD,an investment and networking platform connecting innovative medical startups, physicians, investors, and industry partners, today announced that it has completed a Syndicate funding round for Fibralign, Inc. Fibralign produces therapeutic medical devices that...

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