The company fully meets the conditions stipulated by regulations for producing customized joint bone defect repair products。
Beijing Huakang Tianyi Biotech Co., Ltd. fully meets the conditions stipulated by regulations for producing customized joint bone defect repair products:
1. Possesses professional and technical personnel required for the development and production of customized medical devices, who have also undergone professional training by relevant authoritative physician training institutions and industry organizations;
2. Possesses the capability and research foundation for the development of customized medical devices, and has 3D printers and related supporting equipment;
3. Has registration certificates and corresponding production licenses for knee prostheses and hip prostheses of the same type that are mass-produced according to standard specifications;
4. Has the production capacity and production experience for knee prostheses and hip prostheses of the same type that are mass-produced according to standard specifications, and complies with the YY/T 0287-2017 idt ISO13485:2016 and GB/T 19001-2016 idt ISO 9001:2015 quality management systems.
