MIK - MDR- & IVDR-Competence Centre

The MDR & IVDR Competence Center combines the competencies of the partners NMI Natural and Medical Sciences Institute in Reutlingen and Hahn-Schickard-Gesellschaft für angewandte Forschung e.V.

The competence center’s holistic approach is based on the needs of industry participants. In addition to providing advice and support with regard to approval, analytical and testing methods that are required but not yet available are developed and, if necessary, standardized. In addition to the development of innovative products, our experts support the companies in testing and analyzing the results and interpreting the results.

We support you with the following tasks:

• Check regulatory requirements 
• Design test plans
• Evaluate biological and technical data
• Information on digital health products and software 
• Documentation and QM based on DIN EN ISO 13485 
• Evaluate clinical data and trials •
• Establish a risk management system based on DIN EN ISO 1497

Tests:

• In vitro cytotoxicity according to ISO 10993-5
• Immune response to biomaterials • In vitro degradation tests
• Detection of degradation products (according to DIN EN ISO 10993-13 and -15)
• Antibacterial effectiveness (based on DIN EN ISO 22196 and  DIN EN ISO 20743)
• Pyrogenicity according to Ph. Eur. 2.6.14
• Determination of liquid properties (including viscosity/rheology,  pH value, conductivity) •
• Sample analysis (wide range of protein and nucleic acid analysis) 

Physical-chemical methods:

• Analysis of coating analysis (thickness, cross section, hardness, scratch resistance,  Layer sequence: FIB, SEM, TEM, ellipsometry)
• Topography
• Chemical characterization (based on ISO 10993-18): Influence of  Production, storage, degradation, etc. XPS, FTIR, Raman, SNMS
• Surface wettability
• Check for cleanliness (film and particles)

Is the appropriate testing service not included? We would be happy to help you develop suitable testing methods and support you!