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neocustom

Customized Prosthesis
Titanium 3D Printing

 

Quality

Quality Management System

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Quality

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

Committed to regulatory compliance, NEOORTHO invests in new technologies and employee development to meet customer expectations. The company aims to maintain an effective Quality Management System, diversify its line of implants and orthopedic prostheses, and continuously innovate to ensure the highest quality and safety in its products.

NEOORTHO’s Quality Management System and product line are certified, undergoing 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)