Company News 2026-11-06
FIMAN has once again obtained EN ISO13485 quality system certification
FIMAN announced that its Changchun Smart Factory has successfully obtained the EN ISO 13485:2016 certification for the quality management system of medical devices from the British Standards Institution (BSI), and has also passed the ISO 13485 re-audit simultaneously. The certification covers the design, development, manufacturing, and distribution of medical collagen implants. This is another proof of FIMAN's full-chain quality control capabilities, and lays a solid foundation for the compliance of future active collagen products entering the European market.

