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Customized Prosthesis
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Quality

Quality Management System

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Quality

NEOORTHO has built a Quality Management System to meet the national and international standards of excellence in the production of medical products with a high degree of safety and quality.

NEOORTHO is committed to comply with the regulatory requirements, to invest in new technologies and to develop its employees, to meet the expectations of its customers, aiming: to maintain the effectiveness of the Quality Management System, to diversify, specialize and innovate its line of implants and orthopedic prostheses, ensuring the highest degree of quality and safety in its products, within a process of continuous improvement.

The Quality Management System of NEOORTHO, as well as its product line, are certified and, therefore, are subject to frequent Certification Audits.

Certifications

Quality Management System

ISO
13485:2016
ANVISA
BPF
ISO
37001

Products

FDA
510(k)
registration
ANVISA
registration
INVIMA
registration
ANMAT
registration
COFEPRIS (Mx)
registration
DIGEMID (Pe)
registration
MSP (Eq)