Our health care system is currently undergoing dramatic changes. The demographic development, the scarcity of public funding concomitant with the increasing demand for health services, a rapidly developing information and communication technology, and last but not least, regulatory requirements stipulated by law create challenges for the system on various levels.
The use of information technology in the health care sector aims at digitally linking all stakeholders and processes in health care. This includes both software-based applications and the process workflows supported by them.
Modern information systems effectively support automated data elicitation and communication processes and thus make a major contribution to improving quality and increasing efficiency in health care.
Medical devices support doctors in diagnosis and treatment. Software embedded in these devices controls and regulates them and provides decision-making support to the staff.
IT in Health Care
Fraunhofer IESE provides support to all stakeholders in the health care sector when it comes to developing and testing software-based innovations. The institute assists its customers from the health care domain in developing complex information systems as well as in implementing domain-specific requirements on modern process management.
Medical Devices
Our software and systems engineering approach supports you all the way from the elicitation of requirements on the medical device to validation. Together with our customers, we develop innovative solutions for software development that efficiently fulfill the requirements of IEC 62304, DIN EN 60601-1-4, and ISO 12207, and provide assistance in systematically implementing them in daily practice. We integrate future-oriented methods and techniques that ensure that quality requirements (e.g., in accordance with ISO/IEC25000) are met efficiently and economically. Safety is our top priority in this respect. We use new methods to support you in performing risk management according to ISO 14971 for software, and use techniques such as Failure Mode and Effects Analyses (FMEA) and Fault Tree Analyses (FTA) for analyzing software safety. Custom-tailored quality management approaches (e.g., similar to ISO 13485) are defined as supporting processes.
We want you to benefit from cooperation with us in the following areas:
- User-oriented software systems
- Controllable complexity and variants
- Provable safety and quality requirements
We offer you individual and tailored services based on our competencies:
- Usability Evaluations and User Experience Engineering
- Requirements Engineering and Management
- Architecture-Centric Engineering
- Software Product Line Engineering and Variation Management
- Mobile Applications
- Process Compliance and Improvement
- Safety Engineering
- Quality Measurement and Prediction
Please contact us. We are eager to discuss your individual challenges with you and sketch a solution based on our competencies. We offer:
- Leading-edge software engineering know-how (state-of-the-practice and state-of-the-art empirically validated results and solutions) in all of our competencies
- Neutrality and objectivity
- Independence
- Training, workshops, coaching
- Independent quality/risk analyses and assessments
- Controlled introduction and transfer of new technology
- Customer-specific process and tool consulting, empirical validation
- (Co-)Development of architectures and innovative prototypes