FTI’s operates a Quality Management System registered by ASR Worldwide to be in full compliance with ISO 9001 and ISO 13485. Certificates are available upon request.
International distributors are supplied with a Certificate to Foreign Government, complying with FDA requirements.
FTI is registered with the U.S. State Department Directorate of Defense Trade Controls as a manufacturer of defense articles and in full compliance with ITAR (International Traffic Arms Regulations).
FTI maintains several certifications complying with CE, UL and ETL We are registered with the FDA as a Medical Device Establishment. Certificates available upon request.
Our medical cables are FDA listed Class 1 Medical devices. FDA Class 1 Product Codes are EQH and LXH listed.
Click here for a full technical file for our medical light guides.
Our LO-50 light source is 510K certified.
All electronic components are ETL approved to UL (Underwriter Laboratory) specification(s).
In addition, our light sources for Machine Vision and Microscopy applications are CE approved, including the 2001 power factor correction mandate, for our European customers.
Up-to-date documentation, formal process validations, and an audited compendium of procedures and forms combine to fulfill QA mandates of customers and governing bodies.
