AMSilk’s Quality Management receives certification

This international standard describes special requirements for quality management systems of medical device manufacturers and their suppliers. With this certification, TÜV Süd confirms that AMSilk is a qualified supplier for medical device manufacturers and that it implements stringent industry standards concerning safety and reliability of its products as well as the required risk management procedures.

Moreover, TÜV Süd recertified AMSilk regarding conformity with the international standard ISO 9001:2015. 

Jens Klein, AMSilk CEO, welcomed the certifications as validation of AMSilk’s longstanding commitment to quality management: “We are very pleased that our high standards regarding safety and product quality have been reconfirmed by the TÜV certification. As AMSilk is planning to further reinforce and develop its medical technology business unit, especially the certification according to DIN EN ISO 13485:2016 is an essential milestone in the development of best-inclass products.”