Regulatory Affairs, M.Sc.
Program Structure
The course of study is defined by the curriculum and examination regulations. In the first and second semesters, students can complete four modules each, which always conclude with written exams or portfolio assessments. The practical focus of the four-semester program is demonstrated by a practical project completed during the third semester. The fourth semester consists of the master's thesis and the final colloquium.
Previously, the written exams and parts of the portfolio assessments were completed as a one-day in-person session at the Lübeck University of Applied Sciences. This arrangement is being phased out for students who began their studies before September 1, 2026. For students enrolling for the first time in the winter semester of 2026/27, the exams will be conducted entirely online, and the in-person exam at the Lübeck campus will no longer be required.
Short introduction to Online Examination
The program can be completed while working.
Module name Abbreviation LP Introduction – Systematic Concepts and Legal Aspects (PDF) MP-PF 5 Classification and Essential Requirements (PDF) MP-PF 5 Quality Management (PDF) MP-PF 5 Medical Technology I - Introduction (PDF) MP-PF 5 Summe 1. Semester 20 Module name Abbreviation LP CE Marking and Certification (PDF) MP-PF 5 Clinical Evaluation, Clinical Trials and Clinical Data (PDF) MP-PF 5 Statistics and Quality Assurance (PDF) MP-PF 5 Medical Technology II – Safety Concepts (PDF) MP-PF 5 Summe 2. Semester 20 Module name Abbreviation LP International Markets and Approvals (PDF) MP-PF 5 Medical Device Safety and Surveillance (PDF) MP-PF 5 Practical Project (PDF) MP-PA 5 Wahlpflichtfächer Portfolio 5 Summe 3. Semester 20 Module name Abbreviation LP W1 Audits – Basics and Practice (PDF) MP-PF 2,5 W2 Basics of Business Administration (PDF) MP-K 2,5 W3 Basics of Marketing (PDF) MP-PA 2,5 W4 Communication and Negotiation Skills (PDF) MP-PA 2,5 W5 Medical Technology Lab (PDF) SLb 2,5 W6 Pharmaceutical Law (PDF) MP-PA 2,5 W7 Project Management (PDF) MP-PA 2,5 W8 Artificial Intelligence in Applications - Focus-Project (PDF) MP-PF 2,5 W9 Artificial Intelligence in Applications - Focus Seminar (PDF) MP-PF 2,5 W10 Specific Topics related to Regulatory Affairs I (PDF) MP-PF 2,5 W11 Specific Topics related to Regulatory Affairs II (PDF) MP-PF 2,5 Module name Abbreviation LP Studienabschluss Abschluss (Final Degree) (PDF)
6 Monate 27 Abschlusskolloquium MP-M (60 Min.) 3 Summe 4. Semester 30 Summe Studium 90
