Quality and Guarantee that SUPPORT us

At Orthotoi, our manufacturing quality complies with the most rigorous international regulations, guaranteeing you orthopedic products of excellence that meet the highest quality and safety standards at a global level.

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Product with seal and standards certificate ISO 13485

ISO 13485 is an internationally recognized standard for quality management systems in the medical device industry. It is intended and conceived for use in organizations for the design and development, production, installation, services and sales of health products.

ANSI

Owner of ANAB, it is the American body of the International Organization for Standardization (ISO).

Product with seal and standards certificate IAF

International Accreditation Forum (IAF) is the world's leading forum for accreditation bodies and bodies interested in Conformity Assessment (certification bodies) in the areas of management systems, products, services and personnel.

EC REP

It guarantees compliance with current regulations regarding medical devices manufactured outside the European Union. Regulation 2017/745 on medical devices establishes the obligation for all manufacturers of medical devices established outside the European Union to have a permanent authorized representative who serves as an interlocutor for the health authorities and has a documentary file with the technical information of medical devices