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Medical Devices - Regulatory Affairs Master (I23176)

Medical Devices - Regulatory Affairs

Master of Science

The masterplan for the future!

The practice-oriented Master's programme in Medical Devices - Regulatory Affairs provides professionals from the medical technology industry with in-depth knowledge in the areas of product approval and development, regulatory strategies, quality management and clinical evaluation. The focus is on the specific requirements of the new Medical Device Regulation (MDR). Also covered are related areas such as international regulations and the In Vitro Diagnostics Regulation (IVDR).

The non-consecutive professional degree programme is aimed at persons with relevant professional experience in the field of medical technology and a completed first degree (e.g. Bachelor's, Magister, Diplom or equivalent). Medical Devices - Regulatory Affairs can be taken either as a fee-based Master's programme, or in the form of individual modules (Certificates of Advanced Studies - CAS).

Graduates have excellent career prospects in the medical device industry, consulting firms, accredited testing agencies and regulatory authorities. They assume central roles in the areas of product approval, regulatory affairs, quality management and clinical affairs.

Programme curriculum

The Master's degree in Medical Devices - Regulatory Affairs teaches the basic structure of regulatory systems. Participants are enabled to implement the associated requirements in the context of concrete product developments and to 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, but also examines special topics such as materials, cleaning and sterility, active medical devices and data analysis.

The programme is completed with the master's thesis in the third semester. Graduates of the Medical Devices - Regulatory Affairs programme at the Tuttlingen Campus of Furtwangen University are awarded the academic degree of Master of Science (MSc).

Programme focus

  • Approval of medical devices, EU-wide and internationally
  • Process and quality management
  • Development processes in the field of medical devices (incl. risk management, usability and methods for the safety of medical devices)
  • Technical documentation in medical technology
  • Clinical evaluation, benefit-risk assessment and clinical studies
  • Post market surveillance & vigilance
  • Areas of specialisation - in each case with regard to the associated regulatory issues
    • Materials and life cycle of medical devices
    • SW/IT systems and active medical devices
    • Production and management of medical devices
    • Quality assurance and data analytics

External link opens in a new window:Details on the structure of the programme

Career opportunities

The Master's programme in Medical Devices - Regulatory Affairs prepares students for a career in central positions in the medical technology sector. These include manufacturers of medical devices, but also consulting companies or notified bodies. The programme provides a systematic and comprehensive view of regulatory requirements and related processes.

The degree has an extremely practical orientation - not least due to the proximity to industry in the medical technology centre of Tuttlingen. Graduates are equipped to actively help shape processes in companies. The broad-based content and interdisciplinary orientation of the programme enables them to assume interface functions and integrate perspectives from areas such as quality management, development, production, logistics, quality assurance / analytics, clinical research and customer orientation. Medical Devices - Regulatory Affairs is therefore your personal masterplan for your future!

Application for the MSc in Medical Devices – Regulatory Affairs at Furtwangen University on the Tuttlingen Campus is possible in the summer semester!
Lectures begin on 15 March.

Career paths

You will typically work in one of the following areas:

  • 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

New: individual modules of the "Medical Devices - Regulatory Affairs" degree can be taken as certificates (CAS modules)!

As an alternative to the complete Master's programme, individual modules can be taken. In this case, participants receive certificates of advanced studies (CAS) recognised as academic professional development courses. These modules (CAS modules) typically comprise 15 credit points (ECTS) and correspond to a study effort that is equivalent to approx. 50% of normal professional activity.

A full-time study programme comprises a total of 30 credit points (ECTS) per semester. The Certificates of Advanced Studies can also be collected and used for a Master's degree at a later point in time. Participants can thus start with individual modules and later decide to complete the full Master's programme.

External link opens in a new window:Details on the individual CAS modules and the conditions pertaining to each

Opportunity for employers: provide your employees with professional development opportunities and secure competitive advantages!

Sound knowledge in the field of product approval is becoming an increasingly decisive factor for success in the medical device industry. There is high demand for those who have become specialists as "Regulatory Affairs Managers/Consultants", not least due to the recently introduced Medical Device Regulation (MDR).

As a company, you have the opportunity to support and develop specialists in a targeted manner with the Master's degree programme in Medical Devices - Regulatory Affairs. The expertise thus acquired 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 part-time or part-time and can be extended to five semesters, for example. Alternatively, you can train employees in a targeted manner within the framework of individual CAS modules.

Target group

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 In preparation