ISO 13485 is the globally recognized quality management standard specifically for the medical device industry. It sets strict requirements on risk control, product traceability, raw material management, production environment, inspection and release procedures, serving as a key entry ticket to global medical supply chains.
Focused on the R&D and manufacturing of functional TPU films, Yantai Leo New Material Technology Co., Ltd. specializes in medical-grade TPU breathable films widely used for wound dressings, medical protective membranes and other disposable medical consumables. The covered the full workflow of our medical TPU film production, including incoming material inspection, clean production control, biocompatibility verification, batch traceability and non-conforming product handling.
With this certified quality system, we are capable of supplying traceable, compliant medical TPU film solutions. Our materials support common sterilization methods such as EO and gamma irradiation, while balancing excellent moisture permeability, flexibility and biosafety to meet customized demands from medical manufacturers worldwide.
This certification marks an important milestone for our medical material business. Going forward, Yantai Leo New Material Technology Co., Ltd. will strictly maintain the ISO 13485 system, continuously optimize formulations and film forming processes, upgrade testing capabilities, and consistently deliver stable, high-performance TPU films for global medical partners.
