ToeFX Inc. is happy to announce that we are now ISO 13485:2016 certified. ISO 13485:2016 is an international quality standard for medical devices and is required for registration as a class II medical device. This accreditation is an important milestone for the company and will advance our mission to help the millions of patients suffering from onychomycosis.
In summer 2020, the company underwent a rigorous 3 day audit of our Quality Management System, conducted by Intertek, to ascerain that ToeFX not only has processes in place to meet regulatory requirements specific to the medical devices industry, but that we follow them in designing, building and operating our medical devices.
Our ISO 13485 certificate covers the design, development, and manufacturing of medical devices for onychomycosis. This confirms our team’s dedication to delivering best in class solutions for patients through high quality medical products and services that are reliable, safe and compliant.