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Quality and Regulation

TAG is committed to developing the highest-quality solutions and upholding the highest standards for product quality and customer satisfaction. TAG is ISO 13485 certified. TAG designs and creates products in compliance with and strict adherence to international protocols to ensure improved surgical procedures with the utmost safety. 

At a Glance:

  • TAG is FDA registered and its quality system complies with FDA-QSR requirements.
  • TAG is ISO 13485 certified including CAN/CSA by LNE.
  • The scope of certification covers design, development, manufacturing and marketing of Orthopedic Implants, Disposable and Reusable Surgical Instruments/tools, including Force Gauge for rehabilitation.
  • TAG products are cleared by the FDA and by Canadian licenses. 
  • All TAG products bear the CE Mark according to Annex II (Notified body: LNE).