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.