• Differential equations (modeling with differential equations, linear differential equations, nonlinear differential equations and qualitative methods)
• Fourier analysis (Fourier series, Fourier transform, Laplace transform)
• Statistical estimation and test methods
• Correlation and regression analysis
• Overview of multivariate methods (analysis of variance, multiple regression, principal component analysis, discriminant analysis, cluster analysis)

Integrated course

Continuous assessment: Exercises with immanent examination character

Lecture examination at the end of the course

• Introduction to medical software
• Regulatory framework and standards
• Development cycle and project management
• Software architecture and user interface design
• Verification and validation
• Data security and data protection
• Case studies and current trends

• Lecture, practical exercises, project work (seminar paper and presentation)

Continuous assessment: Immanent performance review

• Fundamentals of continuous and discrete signals
• Deterministic and stochastic signals
• Signal processing and analysis in the time and frequency domain
• Realization of digital filters
• Specifics of biomedical signals, in particular electrophysiological signals
• Methods of digital signal processing and their application in Matlab

• Lecture, practical exercises, project work

Final exam: Immanent performance review

• Introduction to cyber security in the healthcare sector
• IT systems and medical devices in the healthcare sector
• Threats and vulnerabilities
• Methods and tools for protection
• Practical exercises and case study analysis
• Ethics and legal aspects

Lecture, exercise, practical exercises, case study analysis

Final exam: Immanent performance assessment, practical exercises and projects, colloquia and final examination

• Software Process Improvement and Capability Determination (SPICE)
  • SPICE standard (ISO/IEC 15504) for safety-related software
  • Implementation examples
• Standards for medical software
  • IEC 62304: General standards for medical device software
  • ISO 14971: Risk management for medical devices
• MedDev®-SPICE
  • Process reference model for safety-related software in the healthcare sector
  • Integration in IEC 62304
  • Practical examples

• Lectures: Principles and methods of SPICE and MedDev®-SPICE.
• Practical examples: Deepening knowledge and building implementation skills through real-life examples.
• Alternation of theoretical and practical elements: Supporting and guiding students in their learning progress.

Continuous assessment: Immanent performance review

• Fundamentals of software development for the healthcare sector
• Regulatory framework and standards for medical software (IEC 62304, ISO 14971, ISO 13485)
• Waterfall model vs. agile methods for medical software.
• Version control and management of project artifacts.
• Risk management and quality management
• Testing and validation in medical software development
• Basics of cybersecurity in medical software
• Documentation and documentation requirements in the healthcare sector.
• Current trends and technologies in medical software
• Artificial intelligence (AI) and machine learning in medical applications.
• Mobile healthcare (mHealth) and digital healthcare solutions.

Lecture and exercise

Continuous assessment: Immanent performance review

• Introduction to medical technology: historical development and significance, regulations and standards (e.g. MDR, ISO standards)
• Fundamentals of medical devices: physical and technical principles, sensors, actuators and signal processing
• Diagnostic devices: imaging systems (X-ray, CT, MRI, ultrasound), laboratory diagnostic devices
• Therapeutic devices: radiotherapy devices Surgical instruments (e.g. laser, robotics)
• Surveillance and monitoring systems: vital signs monitoring, intensive care devices (e.g. ventilators, dialysis)
• Innovative technologies: Applications of AI and digitalization
• Practical applications: Case studies on specific devices.

Lecture with exercises

Continuous assessment: Immanent performance review

• Fundamentals of risk management: Introduction to ISO 14971 and IEC 62304
• Risk management methods: Application of FMEA and FTA
• Software security assessment: protective measures and security gaps
• Legal requirements: Adherence to regulatory standards and compliance
• Case studies: Practical application of the methods to medical devices

Lectures and group work / practical exercises on risk analysis

Continuous assessment: Immanent performance review

Introduction to Public Health Care

Definition and principles of public health / History and evolution of public health

1. Health Policy and Systems
   • Overview of health system in Austria
   • Health policy and implementation
   • Health economics and financing
2. Public Health Laws and Ethics
   • Legal frameworks
   • Ethical considerations in public health practise
   • Selected topics / examples on public health law and ethics
3. Health promotion and Diseases Prevention
   • Strategies for heath promotion
   • Diseases prevention programs and their impact
   • Behavioural change and models
4. Global Health and International Health Regulations
   • Global health challenges and responsibilities
   • International health regulations and their implications
   • Case studies on global / international health initiatives
5. Emergency Issues in Public Health
   • Addressing new and emerging health threats
   • Public health responses to pandemics and natural disasters
   • Future trends in public health policy and practise

Integrated course with 25% distance learning component

Continuous assessment: Immanent examination character and final written examination

• Basics of environmental management:
• Introduction to the principles of environmental management, including relevant standards such as ISO 14001 and EMAS
• Energy management systems: Implementation and optimization of energy management systems according to ISO 50001 to monitor and reduce energy consumption.
• Use and deployment of "renewable energy sources" for the healthcare sector
• Sustainability strategies: development and implementation of strategies to promote sustainability in the healthcare sector, including the reduction of waste, water consumption and emissions
• Climate protection measures: Measures to reduce the carbon footprint of healthcare facilities, including the use of renewable energy and improving energy efficiency
• Risk management: identification and assessment of environmental and energy risks and the development of risk mitigation plans
• Legal requirements (national and international): Overview of legal and regulatory requirements in the area of environmental and energy management, including reporting obligations

Lecture with exercises

Continuous assessment: Immanent performance review and final written examination

• Sensors and actuators in building automation
• Standardized bus systems and networks in building automation
• Centralized and decentralized automation systems
• Relationship between building automation and technical building management (field level, automation level, management level)
• Comfort and energy management functions in room automation
• Building security and building automation
• Air conditioning and comfort field, control of air conditioning systems, integration of ventilation systems into building automation,
• EIB/KNX bus system in its hardware and software components, building automation with LON-BUS and BACnet using implementation examples

Lecture with exercises

Continuous assessment: Immanent performance review and final written examination

• Medical Device Regulation (MDR): The MDR primarily affects medical devices, but also building technology in healthcare facilities. For example, power supply systems, ventilation systems and emergency lighting must be designed in such a way that they support the safe operation of medical devices. The relevant standards here include:

  • IEC 60601 (safety requirements for medical electrical equipment)
  • ISO 13485 (Quality management systems for medical devices)

• Harmonized standards: The MDR refers to the application of harmonized standards, which often specify abstract legal requirements. In building services engineering, these standards include

  • DIN 1946-4 (ventilation of hospitals)
  • DIN V 18599 (energy assessment of buildings)
  • ISO 50001 (energy management systems)
  • DIN 18017 (Ventilation of living spaces and hygienic facilities)

• National regulations: In addition to the European regulations, there are national regulations that place specific requirements on the planning, construction and operation of medical facilities. These concern, among other things:

  • Building regulations (e.g. MBO in Germany)
  • Hygiene regulations (e.g. RKI guidelines for hygiene and infection protection)
  • Technical safety standards for building technology, such as the requirements for heating, ventilation, air conditioning (HVAC), water treatment and fire protection systems (e.g. DIN 4102 for fire protection)

• Technical standards: Important technical standards that also affect building technology and support the operation of medical devices include:

  • IEC 60601 (safety and essential performance of medical electrical equipment)
  • ISO 13485 (quality management systems in medical technology)
  • DIN VDE 0100 (Electrical installation in buildings)
  • DIN 12899 (Lighting of emergency exit routes)

• Digital health applications (DVG): The Digital Healthcare Act (DVG) in Germany promotes the integration of digital healthcare applications and influences the IT infrastructure in healthcare facilities. Network cabling, data security and data centers are of particular importance here. Important standards:

  • ISO/IEC 27001 (information security management systems)
  • DIN EN 50173 (communication cabling in buildings)

• Essential labeling elements: Specific labeling elements are required for medical devices, which also have an impact on building technology, e.g. through the need for labeling systems and monitoring equipment for medical devices. This concerns standards such as:

  • CE marking (for the marking of medical devices)
  • UDI (Unique Device Identification) for the identification of medical devices
  • ISO 7010 (safety signs in buildings)

Lecture with exercises

Continuous assessment: Immanent performance review and final written examination

• Introduction to artificial intelligence and robotics in medicine
• Basics of machine learning, classification and pattern recognition in medicine.
• Technologies and applications of robots in surgery, rehabilitation and patient assistance.
• Laws, legal regulations and ethical issues, including data protection and data security.

Lecture with exercises and case studies

Continuous assessment: Immanent performance review

• Introduction to the structures of health data
• Data storage and management systems
• Health data formats and standards
• Data protection and security in the healthcare sector

Lectures and interactive workshops

Continuous assessment: Immanent performance review

• Fundamentals of medical data science
• Statistical methods and machine learning in healthcare
• Visualization and interpretation of medical data
• Practical exercises using tools such as Python, R and MATLAB to analyze medical data.
• Analysis of real health data sets (e.g. clinical study data, patient records).

Lectures and interactive workshops

Continuous assessment: Project-based assessments for the analysis of medical data sets.

Final presentation and report on the analysis and results

• Introduction to the development of medical devices: Phases, players and processes
• Regulatory requirements: ISO 13485, FDA, CE certification
• Design and prototyping: design controls, early prototypes and tests
• Verification and validation tests: quality assurance and risk management
• Approval procedure: Documentation and submission for approval
• Market launch and post-market surveillance: maintenance, recall management and long-term monitoring

Lecture with exercises

Final exam: Immanent performance review

• Introduction to the key economic and strategic aspects of setting up a company.
• Overview of the basic concepts and their integration into the overall business system.
• Application of selected methods such as brainstorming, prototyping and creative problem-solving approaches.
• Integration of innovation management into strategic management
• Practical exercises on the implementation of innovation projects in the corporate context, including planning and control.

Lectures, small group work, written elaboration

Continuous assessment: Discussion, presentation, written elaboration

• The course covers leadership theories, communication strategies and conflict management.
• Practical exercises and case studies promote the application of the concepts learned in day-to-day management in order to strengthen the ability to lead teams successfully.

Lectures, practical interactive exercises and case studies, discussions, feedback loops

Continuous assessment: Participation in practical exercises, discussions, case study feedback, peer feedback

• Independent processing of a complex problem from the study program area.
• Critical examination of relevant literature and its application in the project solution.
• Preparation of technical and scientific documentation and presentation of the results to a specialist audience.
• Teaching the interaction of several disciplines through the interdisciplinary nature of the task.

Each student works on an independent task, which is summarized in a written technical-scientific documentation and presented to a specialist audience in a final presentation.

Continuous assessment: Evaluation of the technical-scientific documentation and presentation, including critical discussion of the results obtained.

• Introduction: Overview of the course and its objectives.
• Trends in modern technologies:
  • Use of technologies in building automation.
  • Medical IT and medical technology in the context of hospitals and industry.
  • Analysis of case studies to illustrate the theoretical knowledge.
• The lectures are given by external guest lecturers from the fields of medical technology, medical informatics, building automation, robotics in the medical field, etc.

The course uses various didactic methods, including Lectures by experts from industry and the healthcare sector and working on case studies

Continuous assessment: Written elaboration

• As part of the degree program, an elective subject worth 2 ECTS must be completed:
  • Students choose from an internal pool of open courses at FH Campus Wien.
  • In addition, they can attend courses at other universities and institutes as non-degree students.
• Open courses give students the opportunity to look beyond their own field of study.
• In multi-professional groups, they expand their knowledge of current topics in healthcare, applied life sciences, technology, public administration and/or construction.
• The interdisciplinary exchange promotes valuable impulses for their own field of study.
• The aim is to offer an individual and versatile education that corresponds to personal interests and professional goals.
• Examples of the programs offered by FH Campus Wien include
  • How to Start a Start-Up (2 ECTS)
  • Architectural Theory (1 ECTS)
  • Architectural Theory (1 ETCS)
  • Building Ecology (1 ETCS)
  • Innovative building materials and ecological building materials (1 ETCS)
  • Corporate Law and Human Resource Management (2 ECTS)
  • Sign language course A1.1 (1 ECTS)
  • Clever Studying - Learning Techniques (1 ETCS)
  • Introduction to Clinical Social Work (2 ECTS)
  • Introduction to Socio-Spatial Social Work (2 ECTS)
  • Introduction to Automotive Engineering (1 ECTS)
  • Project Management (2 ECTS)
  • Ethics and Compliance (2 ECTS)
  • Fundamentals of Knowledge Management (2 ECTS)
  • Climate and energy policy (2 ECTS)
  • Austria in current sustainability developments (2 ECTS)
  • Statistics and Quantitative Methodology (2 ECTS)
  • Knowledge in the Public Organization: Theoretical Introduction (2 ECTS)

Lecture, exercise, project - depending on the chosen course

Continuous assessment: Immanent performance review

• Introduction to predictive analytics and its role in healthcare
• Electronic health records
• Statistical techniques and models
• Model building: data collection, cleaning, selection and validation
• Model building for disease prediction, risk assessment and treatment adjustment
• Legal framework and recommendations for ethical analytics in healthcare
• Case studies and applications in real-life scenarios
• Future of predictive analytics in healthcare

Lecture, exercises, project work

Continuous assessment: Immanent performance review

• Critical analysis and discussion of the projects developed in the 3rd semester.
• Writing an English-language abstract for your own project.
• Preparation and realization of the project presentation.
• Ethical foundations and dimensions of responsibility, including the application of ethical concepts in a socio-technical context, with a special focus on the use of technology in medicine and its social implications.

Blended learning with a combination of:

• Interactive theory inputs.
• In-depth exercises in small groups and in plenary sessions.
• Discussions and presentations to deepen the content.

Continuous assessment: - Writing scientific abstracts

- Evaluation of the project work based on ethical guidelines

- Giving a presentation

Regulatory frameworks for medical devices

• Introduction to the EU Medical Device Regulation (MDR)
• ISO 13485 and ISO 14971: Quality management and risk management standards

Implementation of quality assurance processes

• Quality management systems according to ISO 13485: requirements and implementation
• Implementation of processes for monitoring product quality
• Documentation requirements and their implementation
• Process validation and verification during production

Monitoring and continuous improvement

• Monitoring the quality of medical devices on the market
• Post-market surveillance (PMS) and monitoring of medical devices after approval
• Recall management and reporting to regulatory authorities

Practical application and case studies

• Analysis of case studies on quality assurance and monitoring
• Group work: development of quality assurance processes for a fictitious medical device

Lecture with exercises

Continuous assessment: Immanent performance review

Introduction to the regulatory environment for medical devices

• Historical development and current regulation
• Overview of the most important organizations (FDA, EMA, ISO)

Legal and normative requirements

• Medical Device Regulation (MDR) of the EU
• ISO 13485: Quality management for medical devices
• ISO 14971: Risk management for medical devices
• FDA and other national regulatory authorities

Approval procedures for medical devices

• Market surveillance and approval processes in the EU and the USA
• CE marking and FDA approval
• Specific requirements for clinical investigation and post-marketing surveillance

Documentation

• Technical documentation and regulatory submissions
• Risk management

Current trends

• Digital healthcare products and their regulatory challenges
• Special features of the approval of software as a medical device (SaMD)

Lecture/case study analysis

Continuous assessment: Immanent performance review

• Overview of digital health technologies: Wearables, etc.
• Technical basics of telemedicine: network technologies, data transmission, interoperability.
• Electronic health records (EHR) and eHealth systems
• Clinical applications of telemedicine
• Future prospects of telemedicine: artificial intelligence, big data, personalized medicine.

Lectures and interactive workshops

Continuous assessment: Immanent performance review

• Introduction to VR and its components
• Differences between VR, AR and MR in medical applications
• Applications of VR in medicine
• Clinical engineering and integration of VR systems. Designing user-friendly VR applications for medical staff and patients
• Data security, data protection and ethical guidelines when using VR in healthcare
• VR for remote health monitoring: enabling remote consultations and diagnoses

Lectures and interactive workshops

Continuous assessment: Immanent performance review

• Development of research questions and definition of research objectives.
• Formulation of the research design and selection of suitable scientific methods.
• Structure and argumentation of Master's theses.
• Preparation and presentation of the Master's thesis.
• Feedback as well as individual supervision and support during the preparation of the Master's thesis.

Lectures, workshops, presentations by the candidates with subsequent discussions and feedback loops

Continuous assessment: - Presentation with subsequent discussion

- Submission of the disposition

- Submission of the Master's thesis

• Structuring the Master's thesis, developing the research question and the research design.
• Carrying out a comprehensive literature review, including the relevant scientific sources.
• If necessary, conduct empirical work (e.g. survey methodology, data collection, evaluation, documentation of results) or experimental work (e.g. programming, prototype development) using relevant methodological literature.
• Writing the Master's thesis and supplementary documents such as abstract, disposition, scientific poster and, if applicable, demonstration setups.
• Presentation and defense of the Master's thesis as part of an academic examination.

Independent preparation of the Master's thesis under the continuous supervision of an expert editor.

Final exam: Writing a scientific paper with subsequent defense in front of a commission

Students have acquired the ability to analyze complex problems independently and to work on scientific issues methodically. In addition, they should demonstrate their expertise in a specialist area and be able to present results clearly and convincingly.

The teaching methods include holding a defensio in front of a specialist audience in which students present and defend their Master's thesis. This not only enables them to demonstrate their research findings, but also to answer critical questions and present their arguments clearly and convincingly.

Final exam: Defensio of the independently written Master's thesis before a commission