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 13485:2016 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.