We do not only test according to standards (ASTM, ISO, YY, EN, DIN, etc.). We also develop customized, individual solutions adapted to the requirements of your medical devices.
The requirements for product approval have increased worldwide in recent years. Scientifically sound literature research is highly relevant for both approval and research and development of medical devices. As a basic requirement for mechanical safety and clinical evaluation structured Literature Research is an integral part of our scientific consulting portfolio.
The specifications of the standards regarding setup and performance of tests are very strict. Nevertheless, factors of various kinds can influence and affect the performance of the medical device. Such factors can be in the design of the device itself, but also in its interaction of the device with its user within an environment that simulates its real environment of use in all its variety (medical staff, patient). Based on our multidisciplinary background and our expert knowledge, we support you in identifying those factors that affect the safety and perfornance of you device in everyday clinical use and in deriving suitable testing procedures to cover these factors. In this way, application errors and their consequences can be minimized in the development process. In particular, the fulfillment of certain performance criteria of the medical device can be proven in the approval process without the need for time-consuming and cost-intensive clinical studies.
We are characterized by a multidisciplinary background (engineering, mechanics, biomechanics, medicine, biology) and bring each discipline into the focus of implant and material testing. This is critical to the successful development of the most appropriate testing procedures for all types of implant applications. Our multidisciplinary expertise ensures an in-depth understanding of our results, taking into account both the technical and medical state of the art.
SpineServ is closely linked up with the Institute of Orthopaedic Research and Biomechanics, Ulm University, which is known for its scientific excellence.
We carry out further analytical procedures, among others, in cooperation with the ILM Ulm.