ToeFX is now ISO 13485:2016 certified

ToeFX is now ISO 13485:2016 certified 1

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…

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Health Canada approves clinical trial for ToeFX Light Therapy Device

clinical-trial-approved

ToeFX Inc., a Canadian medical device company developing a novel photodynamic therapy for onychomycosis, announced today that it has received Investigational Testing Approval (ITA) from Health Canada. Under the ITA, the company is authorized to begin clinical trials of the ToeFX Light Therapy device in Hamilton, Ontario. Trials are expected to begin in early 2020. The trial’s principal investigator is Dr. Alexander Rabinovich, MD, FRCSC, an orthopaedic surgeon and Assistant Clinical Professor (Adjunct) at McMaster University. Patients may take the online screening questionnaire HERE

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