Quality Policy Statement:

It is the policy of FMI Medical to ensure customer satisfaction through process improvement initiatives and compliance with all customer and regulatory requirements associated with our manufacturing processes.

Quality System

The FMI Medical quality system is structured in compliance with ISO9001:2000, ISO13485:2003 and CGMP(21CFR 820).

FMI will, at the customer’s written request, provide detailed information about our quality system & manual.