ICF Mercantile, LLC is delighted to announce that we have recently been certified as a ISO 13485:2016 company, in addition to the ISO 9001:2015 certification obtained in 2017.
With the implementation of this medical device specific standard of operation, we are abundantly equipped to take on the challenges of participating in the demanding and vital medical device market.  “Risk management, non-conformity prevention, and validation are already crucial aspects of our internal production process”, Dave Ronner, President/Owner of ICF Mercantile says, “we are pleased to be able to go one step further to assure our customers that we are continuously improving our process, and consistency of the products we produce.  This certification solidifies our commitment to the medical device quality standards.”

The addition of the ISO 13485:2016 certification as a yarn producer, means that our entire supply chain is held to a critical quality control standard. From the beginning of the fiber supply chain through our production process, the same set of guidelines are followed as the device manufacturing companies.