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ISO 13485 certified medical device parts supplier

After several months of training and rectification, we obtained the ISO 13485 certification in December 2022. The certified products include metal parts, plastic parts, glass parts and electronic parts of medical devices. After obtaining the ISO13485 certification, the quality of medical parts is stable, thereby ensuring patient safety.


With more than 16 years of history in the medical metal parts industry and 13 years in the glass parts industry, our long-term and stable quality has won customers trust. Having 13485 certified medical parts can help us expand our business market. When there is no 13485 certification, the produced parts are mostly appearance parts and structure parts. With 13485 certificate, we can challenge core components. The requirement for core components is higher and stricter. The 13485 certificate also represents our pursuit of high quality and high requirements.


As a parts supplier of medical devices, the 13485 system can help us meet the medical industry needs. It controls quality stably and effectively so that customers in the medical device industry do not have to worry about the quality of parts leading to project failure. Although we have served many medical industry customers in the past, we just copied the customer's requirements. However, we have not paid attention to the reasons why customers have those needs. After the 13485 authentications, we have a deeper understanding of industry customers. It also has a deeper sense of mission for the concept of protecting health.

This certification is not only the demand of the medical industry, but also our internal desire to improve the enterprise management. Only when one's ability is hardened can one meet higher and more challenges. With the growth of the company's business, we also need to further improve our management level to cooperate with more outstanding companies in the world's top 500. As long as we continue to improve ourselves, we will also become partners with the same height as giants.

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