Clinical Decision Support
We develop and study intelligent software systems to provide safe and evidence-based support for complex clinical processes. We aim to enable professional medical decision-making and adequate patient care by providing modern ICT solutions directly at the point of care.
- Translation of clinical processes into digital solutions - evidence-based and user-friendly (IEC 62366)
- Development and optimization of clinical algorithms in decision support systems.
- Development of software as a medical device according to IEC 62304 within the 13485 QM-System.
- Planning and conducting clinical trials for software validation with our clinical partners.
Translation of clinical processes into digital solutions - Evidence-based and user-friendly (IEC 62366)
- Process analysis at the treatment site (current state analysis, evidence analysis
- Demonstrator development (mockups, functional prototype)
- Evaluation of user-friendliness with patients and clinical specialists (nurses, doctors, etc.). Formative evaluation (development phase) and summative evaluation (final) according to IEC 62366
- Iterative software development process (IEC 62304)
Development and optimization of clinical algorithms in decision support systems
- Evidence analysis and deduction of rule-based treatment instructions
- Data-driven development of drug dosing algorithms
- Statistical modeling to support the algorithm development process
- In-silico validation of algorithms in the field of diabetes
Development of software as a medical device according to IEC 62304 within the 13485 QM system
- Feasibility studies
- Preparation of technical documentation for software as a medical product
- Development using modern technologies (Android, HTML 5, client-server architecture, Secure Web services, HL7, CDA etc.)
- Creation of clinical evaluations/performance evaluations
- Risk management according to EN ISO 14971
- Implementation of conformity assessment procedures
- Conducting market observations (post market surveillance)
Planning and conducting clinical trials for software validation with our clinical partners
- Clinical testing of software as a medical device
- Quality-assured planning and conducting of studies
- Preparation of study submission documents (Investigators Brochure, Risk Benefit Assessment, Compliance with Essential Requirement etc.)
- Clinical data management and statistics
- Clinical interpretation of results