STÜKEN Czechia receives ISO 13485 certification
Rinteln/Hradec Králové, January 1, 2026 – The STÜKEN Group is further expanding its quality-assured production network for medical technology. Following Germany (2019) and the USA (2023) STÜKEN Czechia, with its production plant in Hradec Králové, has now also received ISO 13485 certification.
The STÜKEN Group is one of the world's leading suppliers of deep drawing and stamping technology. Wherever high-precision, small metal components are required the family-owned company delivers efficient and reliable solutions – from prototypes to large series.
STÜKEN MEDICAL bundles the specific requirements of medical technology and supports customers with certified processes and internationally coordinated manufacturing capacities.
"The ISO 13485 certification at our site in Czechia is an important next step in enabling us to leverage the capabilities of our global competence center for stamped parts for our customers' medical technology applications," explains Dirk Hansper, General Manager of STÜKEN Hradec Králové. "Many customers want the reliability of a certified partner for metal stamped parts plus other metal components and services. ISO 13485 contains specific requirements that are crucial for our customers in the medical technology sector. With this certification, we are creating additional security and making it easier for our customers to obtain approval for their end products."
STÜKEN MEDICAL provides information about its extensive expertise at various trade fairs and at www.stueken-medical.com. This includes Class 7 clean rooms, validated cleaning processes and numerous finishing processes such as laser processes, electropolishing, passivation and heat and surface treatment. Our technical and development staff will be happy to meet with you for a personal consultation.