Medical technology
Our health is our most important asset. That is why medical technology companies are constantly researching and developing innovations and products. We support them with our extensive expertise and services.
Automotive know-how for the innovative medical technology of tomorrow
Our many years of experience with the automated testing of embedded systems in compliance with the strict automotive standards of ISO 26262 enable us to test medical devices comprehensively and in a risk-optimized manner. The relevant standards for medical technology (IEC 61508 and IEC 62304) continue to form the basis. We have focused primarily on the automated HardwareInTheLoop (HELP) approach, which can be used efficiently at various test levels.
Our most extensive medical technology project to date was supporting Fresenius Medical Care Deutschland GmbH in starting to automatically test individual system components of an existing therapy system that was being further developed with new features. Existing system tests that had to be carried out manually were replaced by an automated HIL test set of only a few days' duration - a gain not only in terms of the time efficiency of the verification, but also in the degree of coverage and thus the security of the device.
Scope of services
We support our customers at all levels of the right side of the V-model, e.g.:
- Software module tests as white box tests
- (System) component tests as grey or black box tests
- System tests as grey or black box tests
Range of tasks
Tailor-made testing service with over 20 years of experience
We offer our customers a wide range of services in all phases of the development cycle:
- Support in creating a testable requirements basis
- Tailor-made real-time test systems
- Analysis and creation of relevant Test scenarios
- Specification and design by automated Test cases
- Implementation, documentation and Evaluation from automated test runs
- Test and project management-Support
- Processes and evidence according to EN 62304
- Training and Consulting in the area verification
cooperation
The best from both worlds
In order to be able to offer our customers in the medical technology sector an excellent service throughout the entire development process, we cooperate with Schaeffler Engineering. Our respective core competencies complement each other perfectly, which allows us extensive engineering and Testing services from the idea to series launch take over.
iSyst – 20 years of testing experience in embedded systems
- Development of test routines based on the respective required DIN and standard for testing complex assemblies
- Effective combination of test systems, tailor-made test tools and the associated Testing service
- Knowledge of the challenges in medical technology and the optimal constellation of a development and test team
Schaeffler Engineering – 40 years of experience in automotive systems engineering
- Development of complex systems with high functional safety requirements
- Integration of components, modules and complex subsystems into overall mechatronic systems
- Process reliability from the idea to the series – certified development processes according to CMMI -Lvl.3