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A Yes. SINO ORTHO operates under an ISO 13485 quality management system and maintains applicable regulatory registrations and documentation for relevant products and markets.

A For detailed pricing information, please contact our sales team directly.
Our representatives will provide a quotation based on your product selection, order quantity, and shipping requirements.

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Sino Ortho operates under an ISO 13485-certified quality management system that supports the manufacturing and quality control of orthodontic products.

ISO 13485 establishes requirements for medical device quality-management processes. It does not, by itself, represent product approval or market authorization in every country.

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Quality-control and inspection procedures are applied throughout production according to the product category and applicable specifications.

Depending on the product, these procedures may include incoming-material verification, in-process inspections, dimensional and appearance checks, functional checks, and final packaging inspection. Inspection requirements are adjusted according to the design and intended use of each product.