Rod screw system uCentum: Now also available in sterile packaging.
Central spinal systems uCentum and uBase from the Ulm-based medical technology manufacturer now also available in sterile packaging.
Ulm, March 2021. In order to meet the requirements for better traceability of medical devices in the clinical application area within the scope of the new European Medical Device Regulation (MDR), the Ulm-based medical technology manufacturer ulrich medical already packages a large portion of its available products in the spinal systems sector in sterile form. The uCentum and uBase systems can now also be supplied in sterile packaging.
ulrich medical was one of the first German medical technology companies to be successfully audited in January 2020 as part of the changeover to the new, mandatory Medical Device Regulation (MDR). The new regulation goes hand in hand with a significantly increased documentation effort and stricter test criteria compared to the old EU regulation, as well as the obligation to conduct clinical studies. The company has already successfully launched its key products uCentum for dorsal stabilization of the thoracic to lumbosacral spine and uBase, which is used to stabilize the sacrum and ilium in conjunction with uCentum, all in sterile packaging at the end of 2020. This was accompanied by the publication of a validated and certified platform for the company’s electronic product information materials. On the integrated patient page, which is also required by the MDR, patients who have had a product implanted by ulrich medical can read about it themselves to learn more. The page is available via www.ulrichmedical.com/myimplant.
Better traceability, optimized workflow
This also includes the more stringent traceability of implants. As a result, complete documentation is becoming increasingly important for users such as physicians and surgical staff, but most importantly for sterile staff and the managers of the central supply departments for sterile goods. This has led to many hospitals only implementing the documentation guidelines required by the MDR and also the MPBetreibV (Medical Devices Operator Ordinance) using medical device manufacturers who can supply sterile medical products.
Sterile implants make the internal hospital workflow particularly easy because they are clearly assigned by individual patient labels in the respective packaging right from the manufacturer. ulrich medical meets this need in the environment of its clinical target groups by already having a large portion of the available spinal systems packaged in sterile form. Subsequently, this part will be completed.
About ulrich medical
ulrich medical develops, produces and distributes cutting-edge medical technology that makes a significant contribution to health and quality of life. Since the founding of the family-owned company in Ulm in 1912, medical professionals and users worldwide have relied on the expertise of the independent company. The renowned specialist for spinal systems and contrast media injectors relies on the “Made in Germany” quality label, making it one of the few companies in the industry that consistently develops and manufactures its products in Germany. The implants for spinal systems, which are mainly made of titanium, are used for injuries and diseases that have occurred on any part of the spine and are well established internationally. In the field of contrast media injectors for CT and MRI, ulrich medical offers specially developed user solutions that support radiologists with modern diagnostic imaging. The user-friendly handling, excellent quality and proven hygienic safety of the contrast media injectors make them indispensable in everyday practice and were a decisive factor for gaining coveted approval in the world’s largest medical technology market, the USA. ulrich medical is one of the first medical technology manufacturers in Germany to have already been successfully MDR-audited. In addition, the F.A.Z. Institute named ulrich medical one of the “Innovation Leaders of Germany 2020”.