Beijing Huakang Tianyi Biotech Co., Ltd. fully meets the regulatory requirements 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.