BioCompFinder: New NMI service for manufacturers of innovative medical devices

My medical device is highly innovative. But is it also biocompatible? Medical devices with direct or indirect patient contact are subject to strict rules for approval - for good reason. For small and medium-sized enterprises (SMEs) in the sector in particular, this review is therefore as important as it is complicated. With the BioCompFinder, the NMI Natural and Medical Sciences Institute at the University of Tübingen now offers companies valuable information on which parts of ISO 10993 they need to fulfill for the assessment of biocompatibility for their product - including their own services.

Three questions, quick answers - and a lot of expertise at the NMI

The principle of the BioCompFinder is simple. Manufacturers simply have to answer three questions on the website www.nmi.de/biocompfinder: How is the product used, i.e. how does it come into contact with the patient's body? With which parts of the body does the contact occur exactly? Over what period of time? The result follows directly and specifies the necessary tests. At the MDR & IVDR Competence Center (MIK), the NMI has extensive expertise for consulting and also for numerous testing services.

Services for SMEs

"Especially here in the region around the Swabian Alb, Black Forest and Neckar, there are many medical technology companies with great developments. Our BioCompFinder provides them with valuable information on what they need to consider for the approval of their products," explains Dr. Fabian Körte, scientist at the NMI. "But we can do even more at the MIK: we can provide expert advice and carry out some of the tests at the NMI."

About the MIK

MIK is the MDR & IVDR Competence Center of the NMI and Hahn-Schickard, supported by BIOPRO. The aim of the competence center is, among other things, to develop analytical and test methods that are not yet available and to support companies in the development of innovative ideas through to their certification. It was created in response to stricter requirements for medical devices (MDR) and in-vitro diagnostics (IVDR), which pose major challenges for small and medium-sized companies in the sector in particular. The MIK was initially funded by the Baden-Württemberg Ministry of Economic Affairs, Labor and Tourism.