Dongguan Kingsin Product Design Co., Ltd. is a national high-tech enterprise specializing in full-chain solutions for medical devices. Since its establishment in Dongguan, China, in 2015, the company has undergone three strategic upgrades: initially focusing on medical device design verification and prototype engineering services; in 2020, building an EE electronics engineering team and expanding the supply chain management system; and in 2023, completing a full transformation into a medical device manufacturing enterprise, with two ISO Class 7 cleanrooms and a standard testing laboratory (total area of 300㎡), certified under the ISO 13485 medical device quality management system.

By 2024, the company achieved a global layout with an overseas operations center in Singapore and expanded its Dongguan smart manufacturing base to 2,500㎡. The base includes a Class 10,000 dust-free microbiology lab, LSR liquid silicone molding workshop, intelligent MES storage system, and industry-leading precision manufacturing matrix, which includes 450T-100T fully electric injection molding machines, customized precision extrusion lines, microbiology lab, physicochemical analysis lab, pure water preparation systems, and constant temperature and humidity verification environments, all complying with cGMP and ISO 13485 standards.

In 2025, the company plans to complete the full establishment of the factory and, driven by the mission to provide safe, reliable, and regulatory-compliant biomedical products to the world, will offer end-to-end ODM/OEM services from concept design to engineering validation, regulatory filings, and mass production. With a growing team of over 70 professionals, Kingsin supports innovation in the medical device ecosystem, covering areas such as precision injection molding, PCBA assembly, medical device parts, and other biomedical fields. The company continues to drive the maximization of medical product value through systematic technology and remains committed to developing high-quality, high-precision devices that meet specific clinical needs.