Medical Devices - Regulatory Affairs
Earn a master's degree or gain modular professional training while working
The HFU study programme has a course structure which enables participants to work full-time (blocked classroom and online formats, blended learning) and highly practice and industry-oriented content. Certificates of achievement can be directly linked to problems and projects from the student's own company.
The practice-oriented master's programme teaches and further develops knowledge in the areas of product approval and development, regulatory strategies, quality management and clinical evaluation. Participants can implement the associated requirements in the context of concrete product developments and design processes for handling regulatory tasks. The focus is on the entire product life cycle, including development management, production, technical documentation, clinical evaluation and post-market surveillance, as well as on special topics such as materials, cleaning and sterility, active medical devices and data analysis.
The master's thesis is completed in the third or fifth semester of study. The Master's programme in Medical Devices - Regulatory Affairs at the university campus in Tuttlingen is completed with the award of a Master of Science (MSc) degree.
Approval of medical devices (EU-wide and international), process and quality management, development processes in the field of medical devices, technical documentation, clinical evaluation, risk-benefit assessment and clinical studies, post market surveillance & vigilance, specialisation options.
Internal link opens in the same window:Details about the structure of the study programme
Job description and career opportunities
The master's programme prepares students for careers in key positions in the medical devices sector. These include manufacturers of medical devices, but also consulting companies or designated bodies. The programme provides a systematic and comprehensive view of regulatory requirements and related processes.
Fields of work
Fields of activity in which you will typically be able to apply your skills are
- Quality management and regulatory affairs
- Development and product management
- Production and logistics
- Quality assurance, data analytics and control of business processes
- Clinical affairs
- Strategic positions in the implementation of service concepts
- Auditing tasks
Application and booking
For the summer semester 2023, the two modules CAS 1 Fundamentals of Regulatory Affairs and CAS 3 "In-depth Regulatory Affairs" will be offered. With CAS 1, re-entry into the Master's programme is also possible.
Modular structure with CAS certificates
As an alternative to the complete Master's programme, parts of the programme can be taken as individual modules. In this case, participants receive certificates of advanced studies (CAS) recognised as academic further education. The programme consists of four CAS modules and the Master's thesis. Each CAS module comprises 15 credit points (ECTS). This modular structure allows you to study at your own pace and the course can be adapted to professional and family requirements. It is also possible to start with individual modules and later decide to complete the full Master's programme.
Details on the individual CAS modules
Opportunity for employers: Develop skilled employees in a targeted manner and secure competitive advantages!
Sound knowledge in the field of product approval is increasingly becoming a decisive success factor in the medical devices industry. Not least due to the newly introduced Medical Device Regulations (MDR), there is a high demand for "Regulatory Affairs managers and consultants".
As a company, you have the opportunity to promote and develop specialists in a targeted manner with the Master's degree programme in Medical Devices - Regulatory Affairs. The expertise gained in this way will give your company a decisive competitive advantage. Employees can complete the course while working. The programme can be flexibly structured: The three-semester programme can be completed while working and extended to five semesters, for example. Alternatively, you can provide employees with targeted further training within the framework of individual CAS modules.
The MSc in Medical Devices - Regulatory Affairs is aimed at those who already have professional experience of at least 1 year which is relevant to work in the medical technology industrial sector. Applicants from areas such as development, production, logistics and service who have a basic affinity for the subject of quality management / regulatory affairs are also encouraged to apply. Special previous knowledge is not expected, since the course of study starts with basic principles in this field. Academic stipulations require applicants to have a first degree (see study requirements).
A bachelor's degree is not required for participation in individual CAS modules. These individual modules can be used specifically to offer employees professional development opportunities in the area of quality management / regulatory affairs (see above).
- ECTS 90 ECTS
- Programme duration 3 Semesters
- Campus Tuttlingen Campus
- Faculty Industrial Technologies
- Programme begins Summer semester (March), Winter semester (October)
- Application deadline 15 January (summer semester), 15 July (winter semester)
- Entry requirements Completed first degree, see details
- Teaching Language German
- Accreditation Yes (accredited through the university system accreditation)