Stental GmbH is a startup company founded in 2020 with a focus on the development and marketing of implants. Currently, Stental GmbH is developing various stent systems for vascular use. Because the company’s work is subject to a regulated environment and the need for product approval according to MDR, testing is essential. Stental GmbH has therefore decided to purchase their own testing machine. With the zwickiLine 2.5 kN the company can now run tests independently.
The zwickiLine table-top testing machine is used throughout the manufacturing process— from testing prototypes within the scope of R&D, to determination of the optimal product design and performance, and acceptance-related tests according to various ISO and ASTM standards in the verification phase.
As a result of CEO Miko Obradovic’s many years of experience in the medical industry and his involvement with other companies, he was already familiar with ZwickRoell and several of our testing machines. For this reason, testing technology from ZwickRoell was also an integral part of Stental GmbH’s infrastructure design. Stental GmbH not only places great importance on the highest level of quality and reliability in terms of their products, but also in the selection of a testing machine that meets their quality and reliability demands.
ZwickRoell presented a proposal based on the company’s specific requirements. As part of the testing system specifications, everything was designed and coordinated specifically for testing of stents and the corresponding standards. The option to operate the testing machine in horizontal position provides Stental GmbH with a maximum level of flexibility. Commissioning of the testing machine, the testing software testXpert III as well as the DQ/IQ/OQ qualification process were implemented by ZwickRoell on site, and Stental GmbH employees were fully trained on the machine.
Use of this latest testing system from ZwickRoell eliminates the time and cost incurred from external services. In addition, the high level of flexibility when compared to other product designs and their possible direct adaptation further convinced Stental GmbH that ZwickRoell is the right partner when it comes to testing technology.