Quality you can trust
Certifications & Compliance
As an orthodontic medical-device manufacturer, regulatory compliance and consistent quality sit at the heart of everything we make. Our products and quality systems are certified and registered to internationally recognised standards.
Our credentials
ISO 13485
Quality Management — Medical Devices
Internationally recognised quality management system specific to the design and manufacture of medical devices, ensuring consistent regulatory compliance and product safety.
ISO 9001
Quality Management System
Certifies a robust, audited quality management system across our operations — from procurement and production to customer service and continual improvement.
FDA Registered
U.S. Food & Drug Administration
Our facility and devices are registered and listed with the U.S. FDA, meeting the regulatory requirements for marketing orthodontic products in the United States.
CE Marking
European Conformity
CE-marked products conform with the health, safety and environmental protection standards required for sale within the European Economic Area.
Manufacturing quality standards
Over three decades of orthodontic manufacturing experience. Innobrace operates an audited ISO 13485 quality management system, producing every product line — from brackets and archwires to whitening and oral-care systems — under documented, traceable processes with defined controls at each stage.
Our innovation heritage includes the U.S.-patented Flexibrace flexible-archwire-slot bracket — the only bracket system of its kind. It is sustained by an ongoing clinical and materials-science collaboration with Singapore’s SIMTech (Singapore Institute of Manufacturing Technology), reflecting our commitment to evidence-based product development.
Testing & compliance processes
Materials and finished devices undergo verification and validation against the applicable international standards before release. Products destined for the European market are CE-marked in line with the EU Medical Device Regulation, and our facility and devices are registered and listed with the U.S. FDA for the United States market.
Records, complaints handling and continual-improvement reviews are maintained as part of our ISO 9001 and ISO 13485 quality systems, ensuring consistent, regulator-ready documentation.