ISO Certifications

FMI has successfully attained the following ISO certifications which are a testament to our stringent quality systems and customer commitment.  Certifications are based on internationally recognized management system standards developed by the International Organization for Standardization (ISO). FMI is also FDA registered.


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ISO 13485:2003 (FMI U.S. and China)

ISO 13485:2003 is the quality management system standard specific to the medical industry. The requirements emphasize critical areas impacting design, process, quality, and manufacturing reliability for medical device products.

ISO 9001:2008 (FMI China)

ISO 9001:2008 is the general standard which requires companies to establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of the standard.

Learn more about FMI's commitment and offering to the medical industry.