Products & Solutions

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.

Services

Our services

  • 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.
Competence

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