We enable the development of your medical device from the idea to series production. 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.
Quality for your Medical Device 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.
Modern medical technology is no longer conceivable without software development. This applies both to the software directly in the medical devices and to software that accesses the devices as an application from outside. In both cases, you can rely on standard-compliant documentation according to DIN EN ISO 62304.
senetics develops Class I, IIa, IIb and III devices in accordance with 93/42 / EEC (MDR).
Development Competences for Medical Devices
Our team develops all the electronics, enclosures and software for your medical product. In doing so, we always observe the specifications for functional safety for medical devices. Our development team specializes in the development of therapy and diagnostic systems.
The following competences are used for a successful product development:
- Control electronics and control technology
- Selection of a suitable power supply according to EN 60601-1
- Design of mechatronic assemblies
- Material selection taking into account the requirements for medical devices
- Conception of the user interface optimized according to ISO 62366
- Technical drawing and manufacturing (CAD / CAM)
- Development-accompanying tests
- Production of medical devices in series
- Control electronics for hospital beds
- Mobile medical product for vital parameter measurement, e.g. Sphygmomanometer, pulse oximeter
- Electronics for electric wheelchairs
- Mobile ECG
- Mobile cleaning devices for clinical and home care medical products