Master of Science

Medical Devices - Regulatory Affairs Master

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Flexible path to expertise

This programme deals with the approval of medical technology products, process and quality management and development processes in the field of medical devices. The master's can be completed in five semesters while working. It is also possible to take the individual modules to acquire this sought-after specialist knowledge.

  • ECTS: 90 ECTS
  • Programme duration: 5 semesters
  • Campus: Tuttlingen
  • 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)
  • In demand professionals Our medical devices degree programme communicates and deepens knowledge in the areas of product approval and development, regulatory strategies, quality management and clinical evaluation - specialist knowledge that is urgently needed in the medical technology industry!
  • Comprehensively trained The programme content covers the entire product life cycle from development management to production, technical documentation, clinical evaluation and post-market surveillance, as well as areas such as materials, sterility and data analysis.
  • Flexibly customisable As an alternative to the complete master's programme, parts can be taken as individual modules. There are recognised certificates (Certificates of Advanced Studies) for these. The course consists of four modules and the master's thesis and can be taken flexibly.
  • Offer for companies There is an enormous demand for regulatory affairs specialists, not least due to the Medical Device Regulations (MDR). Thanks to our flexible study conditions, companies can enable employees to specialise while working. Fit for the future!

Details of programme

Programme content and structure

The special feature of this degree course is its modularity and its part-time organisation – here, specialist know-how is provided in the right way!

The course is offered in four modules. If these are taken individually, Furtwangen University issues a CAS certificate (Certificate of Advanced Studies).
The cost of attending each module is €3950.

Module 1: Fundamentals

"Fundamentals of Regulatory Affairs and Development Management": We examine the interplay between the various standards and requirements as well as internal company processes. As a solid foundation, the module covers the structure of regulatory systems, their legal basis and their integration into development processes. We delve deeper into the development of medical devices with regard to regulatory issues and work on tasks in risk management and usability. In order to apply the theory, we offer a specific task from the fields of regulatory affairs and development management in the "Regulatory Requirements practical project".

Module 2: Validation

"Quality management and clinical validation": The topic of clinical validation/clinical evaluation has become considerably more important in Medical Device Regulation (MDR). This includes, in particular, an academic approach – both in terms of tests and examinations and in terms of the evaluation of scientific literature. In this module, we develop organisational procedures in a medical technology company, for example quality management systems and the analysis, implementation and introduction of processes. This knowledge is applied to a specific task in the "Quality management and clinical validation practical project".

Module 3: Consolidation

" Consolidation of Regulatory Affairs": This module deals with product approvals that are of great importance in the daily practice of regulatory affairs departments, for example international approvals or audits. We delve deeper into the implementation concepts of regulatory systems, such as the function and management of standards and guidelines or issues relating to ethics and compliance. In the second part of the module, you can choose from material science topics such as biocompatibility, cleanability and the life cycle of medical devices, or electronic or software-oriented topics such as active medical devices or the management of software and IT systems.

Module 4: Application

"Application Regulatory Affairs": In this module, participants can choose a second specialisation. This further specialisation deepens specialist knowledge and strengthens skills in practical implementation, as project work with specific tasks is also required here. This also prepares for the thesis work, as the consistent implementation of academic and, of course, regulatory standards is increasingly required here. There are possible options for specialisation in the areas of production and management tasks or data analysis, in which the field of machine learning/artificial intelligence is also examined.

Entry requirements

In order to be admitted to the master's degree programme in Medical Engineering - Regulatory Affairs, you must have completed a first degree (at a German university or a foreign equivalent, e.g. bachelor's, magister, diplom) with at least 210 ECTS credits.
If the first degree has less than 210 ECTS, additional courses can be taken or other (practical) achievements can be recognised.

The discipline of the first degree must be technical engineering, natural sciences related to medicine, medicine, biology, biochemistry, business administration or law. Admission with a different degree is possible, provided that the first degree is clearly related to the master's degree in Medical Technology - Regulatory Affairs.

In order to be admitted, students must have gained at least one year of relevant professional experience after successfully completing their first degree.

German language skills are a prerequisite for the course.

No previous degree is required for participation in individual CAS modules.

MRA specifics

The master's degree in Medical Technology - Regulatory Affairs is aimed at those who already have relevant professional experience (at least one year) in an area that is relevant to an industrial activity in the field of medical technology. This may also include professionals from the fields of development, production, logistics, service, etc. who have a basic affinity with the subject area of quality management / regulatory affairs. No special prior knowledge is expected, as the course builds up fundamental knowledge in this area. A previous degree is a prerequisite for completing the master's degree.

A bachelor's degree is not required to participate in individual CAS modules. These individual modules can be used specifically for the further development of employees in the direction of quality management / regulatory affairs.
The field of the first degree must be technical engineering, natural sciences related to medicine, medicine, biology, biochemistry, business administration or law. Admission with a different degree is possible, provided that the first degree is clearly related to the Master's degree course in Medical Technology - Regulatory Affairs.

In order to be admitted, students must have gained at least one year of relevant professional experience after successfully completing their first degree.

German language skills are a prerequisite for the course.

No prior degree is required for participation in individual CAS modules.

What's included

Your career prospects

The master's programme prepares students for a career in central positions in the field of medical technology. These include with manufacturers of medical devices, but also with consulting companies or notified bodies.
Typical areas of activity include quality management and regulatory affairs, development and product management, production and logistics, quality assurance, data analytics and control of company processes, clinical affairs, strategic positions in the implementation of service concepts and auditor tasks.

Faculty of Industrial Technologies

The Faculty of Industrial Technologies on the Tuttlingen Campus is something very special. At HFU, all subject areas are taught with a lot of practical relevance– but on the Tuttlingen Campus, students benefit from a special proximity to companies in the region. The focus here is on cooperation with industry in many practicals, students are allowed to work in company labs and can thus also make important contacts for their future careers. At "ITE", we focus our degree programmes on current topics of the future – digitalisation and technologisation, smart materials, medical technology, the energy transition, sustainability and human-machine interaction are just some of the exciting topics that we are helping to shape the future with.

Find out more about the Faculty of Industrial Technologies (ITE)

 

As one of the strongest research universities in the country, HFU is very active in the field of medical technology.

Find out more about the Internal link opens in the same window:current research projects at HFU.

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Your key contact

  •  Prof. Dr. Michael D'Agosto
    Prof. Dr. Michael D'Agosto Dean of Studies Medical Devices - Regulatory Affairs (MSc)
  •  Dr. Armin Müller
    Dr. Armin Müller Head of HFU Academy