Production control in medical technology

Standard metrology is often inadequate for 100-percent quality control in medical device manufacturing. The measurement tasks and the processes in which the measurements have to be integrated are often simply too complex. A consistently documented quality control is indispensable, especially for medical products, because errors can have direct consequences on the health of people. Medical disposables are manufactured in high volumes. For quality assurance, however, a 100-percent component inspection is also required here. This can only be achieved with inline inspection systems that measure up to the micrometer range even at high throughput.

Fraunhofer IPM develops special microscopy systems that monitor production processes in medical technology fully automatically. The microscopes detect structural defects of micromechanical components on the order of a few micrometers. Non-planar geometries of medical components or composite systems of different materials present a challenge for developers. Depending on the scenario, Fraunhofer IPM adapts the microscopes to complex geometries and special properties. For the construction and testing of the systems, a class 100 and 1000 is available at the institute. Thus, the systems can be developed and tested under the conditions of medical technology production. Software adapted to the systems including a database link is an important component of the in-line microscopy systems from Fraunhofer IPM.