Quality Systems and Regulatory Information


FOBI Medical is registered with the US Food & Drug Administration (FDA).  To view our registration information, please use the link below.  [This link will take you to the FDA’s establishment registration and device listing database.]

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