We take over the development of subassemblies, accessories and complete in-vitro diagnostics (IVD) from the idea to series maturity. In doing so, together with you we work out a way to turn your idea into a patent or your technology into a product. Come to us. We find a way to bring your idea to the user.
Qualität for IVDs according to ISO 13485
Our development department covers the expertise required for your projects through a wide range of expertise. In this way we can guarantee an efficient handling of the problems entrusted to us by fast communication among the departments and experts. All development processes are implemented in accordance with DIN EN ISO 13485. This includes an accompanying risk analysis and evaluation according to DIN EN ISO 14971 for all development activities.
Competencies for the development of IVDs
Our team develops products of medical technology and miniaturized sensors for you. In doing so, we always observe the specifications for functional safety for medical devices. Our experience ranges from injection molding of a wide variety of plastics, through metal housings to the integration of modern capacitive input systems. Furthermore we can simulate a stress analysis of the critical elements, e. g. support structures.
- Development of miniaturized sensor modules
- Development of the readout unit including firmware development according to IEC 62304
- Product design
- Optimization of mobile energy supply
- Use of innovative sensors for the analysis of liquids and substances
- Technical drawing and manufacturing (CAD / CAM)
- Development of antibacterial surfaces
- Development-accompanying cleaning validation
- Development of reactors for biological tests
- Selection of materials considering biological safety according to ISO 10993
- Drug application, e.g. Intake of insulin
- Injectors with integrated sensors for measuring the level and environmental parameters
- In-vitro diagnostics with integrated optical sensors