ISO 13485 认证 - STÜKEN 北美

The successful certification is proof of the high quality and reliability that STÜKEN delivers to its customers worldwide.

Fountain Inn/Rinteln, May 23rd, 2023 – STÜKEN North America with its production plant in Fountain Inn, South Carolina, USA, has received ISO 13485 certification.

The global STÜKEN Group is the world market leader for deep drawing technology. Wherever small and precise components made of metal are required, the family-owned company delivers outstanding quality and economical solutions. The STÜKEN MEDICAL business division takes care of the needs of its medical technology customers. The German headquarters has been certified according to ISO 13485 since 2019. Now, the group's North American site has also attained this significant certification.

"This is an important next step towards being able to manufacture STÜKEN MEDICAL's proven deep-drawn parts in a certified manner in the US," explains Dr. Dennis Gossmann, Vice President and General Manager of STÜKEN North America. "Many customers require the reliability of a certified partner for metal deep-drawn parts. ISO 13485 contains specific requirements that are crucial for our medical technology customers. With this certification, we create additional security and make it easier for our customers to get their end products approved."

Press contact

Hubert Stüken GmbH & Co. KG
Sandra Göhner-Baake, Marketing Manager                      
Phone: +49 5751 702 0