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Quality System


China production center has passed the quality management system GB/T 42061-2022 idt ISO 13485:2016, GB/T 19001-2016 idt ISO 9001:2015;

Vietnam production center has passed the quality management system ISO 13485:2016 and ISO 9001:2015;

In the production process, key processes are strictly controlled and verified. The first inspection, in-process inspection and special inspection processes are applied to each process to meet the conformity requirements of products and designs;

Raw materials, semi-finished products and finished products are sampled according to AQL standards; Batch number management is established for each product to achieve product traceability.


Qualification certification


China production center has passed Class II and Class I medical device certificates issued by China CFDA, obtained safety production standardization certificate, and passed the US FDA registration and Sedex social responsibility audit;

Vietnam production center has passed the US FDA registration and Sedex social responsibility audit; It provides a strong guarantee for the standardized management and orderly production of enterprises.