Quality Systems and Regulatory Information


FOBI Medical is registered with the US Food & Drug Administration (FDA).  To see our registration information, please use the link below to be taken to our current registration information.

FOBI Medical is committed to the highest level of quality and safety.  As such, we have implemented an ISO 13485 compliant Quality Management System (QMS) and been audited by an external organization to insure our compliance.  For a printable copy of our certificate, please click the link below.