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."
STÜKEN MEDICAL will provide information on its extensive competencies, including Class 7 cleanrooms, validated cleaning processes and numerous finishing processes such as electropolishing, passivation and heat as well as surface treatment at the MedtecLIVE with T4M trade show in Nuremberg, Germany, May 23-25, 2023 - Hall 3C, Booth 3C-312. Technical and development contacts will be available for on-site discussions.
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."
STÜKEN MEDICAL will provide information on its extensive competencies, including Class 7 cleanrooms, validated cleaning processes and numerous finishing processes such as electropolishing, passivation and heat as well as surface treatment at the MedtecLIVE with T4M trade show in Nuremberg, Germany, May 23-25, 2023 - Hall 3C, Booth 3C-312. Technical and development contacts will be available for on-site discussions.
