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Xunfeng obtains medical ISO 13485 certification

Based in Zhuhai (China), Zhuhai Xunfeng Special Plastics Co Ltd., the latest member of the Wittenburg Group is now qualified under the integrated quality management system for medical devices “ ISO 13485 “.

The Xunfeng facility uses proven international technology and quality systems to support the Chinese market with medical compliant polymer compounds. The main reason to build the plant is to supply the existing customer base with proven and reliable products in China. The qualification under ISO 13485 is a major step in achieving the goals of the Xunfeng organisation to support producers of medical device and pharmaceutical packaging with trustworthy and reliable products minimizing potential risk for (ill) humans. At the same time Xunfeng belongs to the first Chinese companies certified to the new ISO 9001:2015 norm. Wittenburg

The Xunfeng plant has several production lines with a total capacity of 6500 MT/year, a fully equipped quality control lab and importantly uses high quality and fully qualified raw material. Customers will be supported by a dedicated local Chinese speaking sales team. The intellectual property of Wittenburg Group and its customers are secured by local western management and protective infrastructure.

Xunfeng is a high quality supplier of TPE and speciality engineering plastic products as used in medical devices and Pharmaceutical packaging and also for products in direct contact with food or drinking water for the Asian market. Xunfeng is focused on minimising and controlling any risk customers and end users could have regarding the functionality and performance of their products. Customers can expect professional R&D and product safety support.

The Wittenburg Group is active in the design and production of soft TPE materials and specialty engineering plastic compounds. For over 100 years, Wittenburg has built a strong international reputation when it comes to technical achievements, innovation, quality and reliability. The company group is based on a strong Research & Development ethos which allows delivering technical solutions for highly regulated markets. Now with 3 production sites, Wittenburg Group has the flexibility to support customers worldwide with dedicated compounds in batch sizes from 10 kg to full container loads, based on over 30 base resins.