On January 2, 2024, ProteinT successfully obtained the GB/T 42061-2022 idt ISO 13485:2016 Medical Device Quality Management System Certification. The certification scope covers the design, development, production, and service of sample release agents, protein and polypeptide extraction or purification reagents, and single-use sampling tubes; as well as the design, development, entrusted production under the registered-person system, and service of polypeptide composite quality control materials.

Chinese Certificate

English Certificate

This certification represents a stricter and more professional specification and supplement to the general ISO 9001:2015 standard certification. It marks that our medical device quality management system has met international standards and regulatory requirements, and is of great significance to the further improvement of product quality, the enhancement of customer satisfaction, and the strengthening of market competitiveness. In the future, ProteinT will continue to comprehensively enhance its innovation and service capabilities with more professional standards, provide physicians and patients with safer, more reliable, and more professional clinical proteomics solutions, and continue to contribute to the advancement of medicine!