In the medical device industry, ISO13485 certification is an important mark of a company’s quality management system. Pingchuang Medical, as a professional OEM/ODM manufacturer of personal lubricants, boasts a 16,000 square meter production base and has obtained ISO13485 certification. This certification not only recognizes our product quality but also serves as an essential guarantee for our foothold in the global market.
Pingchuang Medical’s production base is located in Foshan, Guangdong Province, with a well-organized layout and efficient production processes. Our production lines utilize advanced automated equipment, enabling efficient production and strict quality control. Through ISO13485 certification, our quality management system covers every aspect from raw material procurement, production process control to finished product testing, ensuring every batch of products meets international standards.
During production, Pingchuang Medical strictly adheres to GMP standards to ensure product safety and efficacy. Our production base features a 100,000-level cleanroom, effectively preventing external contamination and ensuring product purity. Every employee must undergo strict disinfection procedures before entering the cleanroom to maintain a clean production environment.
Pingchuang Medical’s products have been exported to 76 countries, including North America, Europe, and Southeast Asia. To meet the diverse market demands of different countries, our R&D team continuously innovates and develops lubricants that comply with various national standards. Our products have not only obtained FDA 510K and CE certifications but have also passed multiple international standard tests, ensuring competitiveness in the global market.
In expanding into international markets, Pingchuang Medical emphasizes communication and collaboration with clients. Our professional team provides customized solutions based on client needs, including product formulation, packaging design, and market promotion. Through one-stop services, we help clients quickly enter the market and maximize commercial value.
Pingchuang Medical’s success stems not only from high-quality products but also from our keen market insights and deep understanding of customer needs. We always adhere to a customer-centric approach, continuously enhancing product quality and service levels to secure a place in the global market.
