MIK - MDR & IVDR competence center
Consulting, development support, and testing of medical devices: we support you every step of the way, from the initial idea to the certification of your innovative products!
As a competence center, MIK offers consulting, development support, and testing of medical devices in line with the needs and requirements of the industry. Thanks to MIK's holistic approach, we can support you every step of the way, from the initial idea to the certification of your innovative products.
The MDR & IVDR Competence Center brings together various areas of expertise within the NMI and is supported by BIOPRO Baden-Württemberg.
We provide and arrange consulting services and accompany you through to the certification of new products. To this end, we develop new analytical and testing methods as required. In addition, we support companies in interpreting the results of testing and analysis.
We support you with the following tasks:
- Reviewing regulatory requirements
- Designing test plans
- Evaluating biological and technical data
- Documentation and QM based on DIN EN ISO 13485
- Evaluating clinical data and tests
- Establishing a risk management system based on DIN EN ISO 14971
- Product- and application-specific tests
Biological and other analyses:
- 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 efficacy (based on DIN EN ISO 22196 and DIN EN ISO 20743)
- Pyrogenicity according to Ph. Eur. 2.6.14
- Determination of fluid properties (including viscosity/rheology, pH value, conductivity)
- Sample analysis (broad spectrum of protein and nucleic acid analysis), e.g., for the creation of reference samples
Physical-chemical methods:
- Coating analysis (thickness, cross-section, hardness, scratch resistance, layer sequence: FIB, SEM, TEM, ellipsometry)
- Surface topography
- Chemical characterization (based on ISO 10993-18): influence of production, storage, degradation, etc. XPS, FTIR, Raman, SNMS
- Surface wettability
- Cleanliness testing (film contaminants and particles)
Can't find the right testing service? We would be happy to develop new testing methods tailored to your needs!
