The 3D-Center of Orthopedics at the UKM
Center for 3D Data Processing and Additive Manufacturing
This project will create a cross-clinic center for additive manufacturing directly at the point of care. Thanks to a qualified production environment (in accordance with ISO/ASTM 52920) based on the UKM's quality management system in accordance with ISO 13485, the manufacture of medical devices using additive manufacturing can be researched in a clinical environment in compliance with the MDR. The immediate proximity and integration into the Clinic for General Orthopaedics and Tumor Orthopaedics and close cooperation with the Clinic for Radiology enables an optimal exchange between clinicians and researchers. We proceed in conformity with the Medical Device Regulation (MDR) EU 2017/745 according to Article 5(5). This ensures that our products, which benefit patients, meet the highest requirements with maximum safety. The close exchange with the treating physicians enables us to find individual solutions that redefine the standard of medical care. The time factor plays a key role here. This means that we can act within the shortest possible time if necessary and clinically urgent.
At the heart of the 3D center are additive manufacturing processes for the medical material PA12 (polyamides) and biocompatible resin-based plastics. After sterilization, a 3D printed part can also be used in the operating theatre and on the human body. In order to raise research in this area to a maximum safety level, the production process and the associated process chain are to be certified in accordance with international standards. This also includes extensive structural measures that are still in the implementation phase.
At the heart of the 3D center are additive manufacturing processes for the medical material PA12 (polyamides) and biocompatible resin-based plastics. After sterilization, a 3D printed part can also be used in the operating theatre and on the human body. In order to raise research in this area to a maximum safety level, the production process and the associated process chain are to be certified in accordance with international standards. This also includes extensive structural measures that are still in the implementation phase.
Contact: 3d-center@ukmuenster.de
Further information on research in the field of additive manufacturing at the point of care can be found here.
The 3D Center was supported by the REACT-EU funding program. Find out more here.
