BioCompFinder now available in English

Biocompatibility is an important criterion for the approval of new medical devices that come into direct or indirect contact with patients. For small and medium-sized enterprises (SMEs) in the sector in particular, checking this is therefore as important as it is complicated. For this reason, the NMI has developed the BioCompFinder. After answering just three questions, companies receive valuable information on which parts of ISO 10993 they need to fulfill for their product to assess biocompatibility – and find out what services the NMI offers. This online questionnaire is now also available in English.

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/en/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.

About the MIK

MIK is the MDR & IVDR Competence Center of the NMI, 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.

Date:
28.01.2025
Categories:
Aktuelles