• 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)

• After completing the course, students will be able to apply differential equations for modeling in the natural sciences and medicine and have basic knowledge of their solution methods.

• After completing the course, students will be able to use the mathematical methods of Fourier analysis for signal processing in order to transform signals between the time and frequency domains.

• After completing the course, students will be able to apply basic statistical estimation and testing techniques, including point and interval estimation and parametric and non-parametric significance testing, and have an overview of bivariate and multivariate techniques.

• After completing the course, students will be able to use a statistical program package for the practical application of statistical procedures in a medical context and interpret the results appropriately.

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

• After completing the course, students will be able to understand and apply basic regulatory requirements and quality standards for medical software (e.g. ISO 13485, IEC 62304).

• After completing the course, students will be able to explain the development process of medical software and describe the most important phases such as analysis, design, implementation, testing and documentation in the context of regulatory requirements.

• After completing this course, students will be able to apply the principles of verification and validation to check the functionality, reliability and safety of medical software.

• After completing the course, students will be able to explain suitable techniques for the protection of sensitive health data and analyze their significance in the development of medical software.

• After completing the course, students will be able to design simple medical software solutions that take into account the requirements of user-friendliness and data integrity and present their solutions using concrete examples.

• 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

• After completing the course, students will be able to use the Matlab software to analyze and process basic electrophysiological time series.

• After completing the course, students will be able to create a program for signal acquisition and correctly select the parameters of the acquisition system depending on the type of biomedical signal.

• After completing the course, students are able to master the application and properties of the Fourier transform and the Z-transform.

• After completing this course, students will be able to distinguish the characteristics of basic electrophysiological signals (EEG, ECG, EMG) in the time and frequency domain.

• After completing the course, students will be able to select and apply different filter methods depending on the characteristics of the signal to be processed and the type of further application of this signal.

• After completing the course, students will be able to create a user interface for processing and displaying signals and appropriately display the time series and the processing result in the time, frequency and time-frequency range.

• 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

• After completing the course, students will be able to understand basic concepts of cyber security in the healthcare sector.

• After completing the course, students will be able to identify and analyze specific threats and vulnerabilities.

• After completing the course, students will be able to apply suitable protective measures and safety protocols.

• After completing the course, students will be able to carry out risk assessments and recognize protection methods.

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

• After completing this course, students will be able to independently define, manage and successfully complete software development processes in the healthcare sector.

• After completing the course, students will be able to implement specific requirements for the development of medical software in order to increase patient safety.

• After completing the course, students will be able to apply and successfully implement the steps of the MedDEV-SPICE development model.

• 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.

• After completing this course, students will be able to understand and apply the basics of software development specifically for the healthcare sector.

• After completing the course, students will be able to recognize relevant development standards and guidelines and implement them in software projects in the healthcare sector.

• After completing the course, students will be able to apply best practices and agile methods effectively in software development.

• After completing this course, students will be able to integrate quality and risk management processes into software development projects in order to ensure high standards and security.

• After completing the course, students will be able to carry out tests and verifications of medical software during the development phase to ensure compliance with the required quality standards.

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.

• After completing this course, students will be able to explain the technical basics of medical devices and describe how they work.

• After completing the course, students will be able to identify different types of devices and name their specific areas of application in modern medicine.

• After completing this course, students will be able to understand the importance of safety and quality standards for the development and operation of medical devices.

• After completing the course, students are able to analyze practical application examples of medical devices and evaluate their effectiveness and safety.

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

• After completing the course, students will be able to understand the essential standards, such as ISO 14971 and IEC 62304, and apply them to medical devices.

• After completing this course, students will be able to apply risk analysis methods such as FMEA (Failure Mode and Effects Analysis) and FTA (Fault Tree Analysis) to identify and minimize risks in medical devices.

• After completing this course, students will be able to understand and implement safety assessment and software risk management in medical devices.

• After completing the course, students will be able to demonstrate and ensure the legal duty of care and responsibility when handling medical systems.

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

• After completing the course, students will be able to understand the key principles and approaches in the field of public health and apply and implement this knowledge in their professional environment.

• After completing the course, students will be able to name the most important international and national organizations for the implementation of public health initiatives and take into account the corresponding regulatory requirements and legal framework conditions.

• After completing the course, students will be able to use their knowledge of regulatory requirements to help shape new approaches in the field of public health and actively promote their implementation.

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

• After completing the course, students will be able to develop strategies to promote sustainability and implement them in their organizations with the aim of reducing waste, water consumption and emissions.

• After completing the course, students will be able to take measures to reduce their carbon footprint, including the use of renewable energies and the optimization of energy use.

• After completing the course, students will be able to identify risks in the area of environmental and energy management and develop and implement plans to reduce these risks.

• After completing the course, students will be able to gain an overview of the relevant legal and regulatory requirements, 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

• After completing this course, students will be able to explain the functionality and use of sensors and actuators in building automation.

• After completing this course, students will be able to explain standardized bus systems and networks in building automation and evaluate their possible applications.

• After completing this course, students will be able to differentiate between centralized and decentralized automation systems and analyze their respective advantages and disadvantages.

• After completing this course, students will be able to describe the relationship between building automation and technical building management at the field level, automation level and management level.

• After completing this course, students will be able to understand comfort and energy management functions in room automation and describe their role in building efficiency.

• After completing this course, students will be able to explain concepts of building security in relation to building automation.

• After completing the course, students will be able to understand the principles of air conditioning and the comfort field and explain the control of air conditioning systems and the integration of ventilation systems into building automation.

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)

• After completing the course, students will be able to familiarize themselves with the relevant European and national regulations, standards and guidelines that apply to buildings and areas used for medical purposes and to apply and implement these for their tasks.

• After completing the course, students will be able to react to changes in regulations and integrate them into existing procedures and processes.

• After completing the course, students will be able to identify the specific regulatory requirements for various medical devices and systems and derive the resulting requirements for 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.

• After completing this course, students will be able to analyze and define technical requirements and specific fields of application for AI and robotic systems in the healthcare sector.

• After completing the course, students will be able to design concepts and prototypes for AI-supported and robotic devices that meet the requirements of medical practice.

• After completing the course, students will be able to plan and carry out the implementation and integration of intelligent medical devices in clinical environments.

• After completing the course, students will be able to consider safety, ethical and regulatory aspects in the development and application of AI and robotic systems in the healthcare sector.

• After completing the course, students will be able to evaluate the performance and efficiency of AI and robotics systems and identify optimization potential.

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

• After completing the course, students will be able to understand and apply the basic structures and organization of health data.

• After completing the course, students will be able to identify different formats and standards in health data management and use them in a targeted manner.

• After completing the course, students will be able to apply techniques for data cleansing and pre-processing, taking into account relevant legal and ethical guidelines for the protection of patient privacy.

• After completing this course, students will be able to use and implement databases and storage systems that have been specially developed for the healthcare sector.

• After completing the course, students will be able to analyze and interpret health data in accordance with regulations.

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).

• After completing the course, students will be able to understand the basics of medical data science and recognize its applications in healthcare.

• After completing the course, students will be able to analyze complex health data, including clinical study data, medical image data and genome data, and evaluate them for medical and clinical findings.

• After completing the course, students will be able to apply statistical methods and machine learning specifically to health problems and interpret the results obtained in a professional manner.

• After completing the course, students will be able to apply visualization techniques to present clinical data in order to make data understandable and usable.

• After completing the course, students will be able to validate clinical decision support systems from an ethical and clinical perspective and critically evaluate their significance in clinical practice.

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

• After completing this course, students will be able to understand and describe the complete development cycle of medical devices.

• After completing the course, students will be able to recognize norms and standards, such as ISO 13485 and IEC 60601, and explain their significance for the development of medical devices.

• After completing this course, students will be able to apply methods for risk analysis and quality management in the development process.

• After completing the course, students will be able to create development documentation and understand and practically apply approval processes.

• After completing the course, students will be able to explain the principles of design controls and implement the requirements for the approval of medical devices.

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.

• After completing the course, students are able to independently create a business case that covers the basic economic and strategic aspects of founding a company.

• After completing this course, students will be able to explain the basic concepts of innovation management and classify their significance in the context of a company's strategic management.

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.

• After completing this course, students will be able to identify various management theories and approaches, analyze their strengths and weaknesses and discuss their applicability in different business contexts.

• After completing the course, students will be able to develop strategies for effective communication within teams and apply techniques for conflict resolution, whereby role plays and case studies will strengthen their understanding of interpersonal dynamics and their ability to deal constructively with conflict.

• After completing the course, students will be able to successfully build and motivate teams by analyzing factors of team dynamics and applying methods to increase team performance, such as goal setting, feedback and reward systems. Practical exercises support the implementation of these concepts in everyday management.

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.

• After completing the course, students are able to independently plan, carry out and document a technical project from the field of study by developing a consistent concept, working out scientifically sound solutions and presenting the results in a professional manner.

• After completing the course, students will be able to create scientific and technical documents accurately and present the content to a specialist audience in a targeted manner, clearly demonstrating the relevance of the subject-specific literature used.

• After completing the course, students will be able to critically examine relevant literature and incorporate it into their project work in order to develop an application-oriented solution.

• After completing the course, students will be able to understand and apply the interaction of different subject areas in order to effectively solve complex, interdisciplinary problems.

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.

• After completing this course, students will be able to describe a variety of applications in the healthcare sector.

• After completing the course, students will be able to identify the appropriate use of technologies in an industrial environment and in a hospital context.

• After completing the course, students will be able to assess the use of technologies in building automation.

• After completing this course, students will be able to describe medical IT and medical technology in the context of hospitals and industry.

• After completing the course, students will be able to analyze case studies to illustrate their theoretical knowledge.

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)

• After completing the course, students are able to deepen their knowledge in an area of their interest within the framework of the course.

• After completing the course, students are able to work in multi-professional groups and deepen their knowledge in interdisciplinary exchange with students from other degree programs.

• After completing the course, students are able to "look beyond the horizon" of their own study program and gain valuable ideas for their own subject area through interdisciplinary exchange.

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

• After completing the course, students will be able to understand the basic concepts and methods of predictive analysis for the needs of healthcare engineering.

• After completing the course, students will be able to recognize the most important sources of health data, such as electronic health records, population data, sensor data and socio-demographic information.

• After completing this course, students will be able to develop and apply predictive models to identify health risks, predict disease, optimize resources and adapt patient treatment.

• After completing the course, students will be able to analyze and interpret the results of the models in order to make informed decisions and improve the quality of healthcare.

• After completing this course, students will be able to understand the ethical, legal and security aspects associated with the collection, processing and analysis of health data.

• After completing the course, students will be able to use additional resources to independently deepen their knowledge of the application of 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.

• After completing the course, students will be able to structure and write abstracts and academic papers in English, taking into account formal and linguistic criteria, including gender-neutral language.

• After completing the course, students will be able to present technical projects and scientific papers convincingly to an examination board in English and answer questions in a well-founded manner.

• After completing the course, students are able to critically analyze project results by comparing their own approach and results with the state of the art and taking ethical aspects into account and reflecting on the extent to which the project works well and corresponds to good scientific practice.

• After completing this course, students will be able to analyze the ethical foundations and social effects of the use of technology, especially in the field of medicine, and relate them to relevant ethical concepts and social responsibility.

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

• After completing the course, students will be able to explain and practically implement the key regulatory requirements for medical devices, including the EU Medical Device Regulation (MDR).

• After completing the course, students will be able to understand quality management systems in accordance with ISO 13485 and ISO 14971 and apply them in the development and production of medical devices.

• After completing this course, students will be able to implement and monitor quality assurance processes during production and after market entry.

• After completing the course, students are able to know and apply the requirements for documentation and reporting in the context of market surveillance.

• After completing this course, students will be able to develop strategies for risk management analysis and efficiently implement quality assurance measures.

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)

• After completing the course, students will be able to understand and apply the basic regulatory requirements for the development and approval of medical devices.

• After completing the course, students will be able to understand the most important international standards, such as ISO 13485, ISO 14971 and the EU Medical Device Regulation (MDR), and implement them in practice.

• After completing this course, students will be able to analyze and explain the main differences between the regulatory frameworks of the USA (FDA), the EU (MDR) and other international markets.

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.

• After completing the course, students will be able to identify and describe the components of digital health technologies and telemedicine.

• After completing the course, students will be able to critically analyze the application of telemedicine in diagnostics, interventions, monitoring and treatment, including the role of clinical engineers in system integration and problem solving.

• After completing the course, students will be able to implement electronic health records (EHR) and eHealth systems from an engineering perspective.

• After completing the course, students will be able to analyze the legal, regulatory and technical aspects of implementing telemedicine technologies in nursing care, particularly with regard to data protection and compliance with the General Data Protection Regulation (GDPR).

• After completing the course, students will be able to understand the role of clinical engineers in initiating digitalization initiatives in healthcare systems, with a focus on the integration and optimization of digital health technologies.

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

• After completing the course, students will be able to explain the basic principles and technologies of virtual reality (VR), including the necessary hardware and software components.

• After completing this course, students will be able to analyze and evaluate the applications of VR in medicine.

• After completing the course, students will be able to design and implement VR solutions in medical environments.

• After completing the course, students will be able to understand and apply regulatory and ethical guidelines when implementing VR systems in the healthcare sector.

• After completing the course, students will be able to develop VR applications for specific medical scenarios, such as the training of medical staff, patient rehabilitation or pre-operative planning.

• After completing the course, students will be able to critically evaluate the challenges and opportunities of implementing VR technologies in healthcare systems.

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.

• After completing the course, students are able to define a Master's thesis topic and formulate a precise, research-relevant question.

• After completing the course, students are able to create a draft topic for their Master's thesis based on systematic research into the current state of research (state of the art).

• After completing the course, students will be able to develop a Master's thesis outline that clearly structures the research objectives, methods and line of argument.

• After completing the course, students are able to present the results of their Master's thesis as part of the Master's examination and defend them in the subsequent discussion.

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.

• After completing the course, students are able to independently write a scientific paper at Master's level that meets the requirements of scientific methodology and argumentation.

• After completing the course, students are able to summarize the results of the Master's thesis in various scientific formats, including a scientific poster and, if necessary, demonstration objects, short video presentations or prototypes.

• After completing the course, students are able to present and defend their Master's thesis convincingly in both German and English in an academic defense in front of an expert committee.

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.

• After completing the course, students will be able to analyze complex problems independently and work on scientific issues methodically.

• After completing the course, students will 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