Medical device manufacturers are obliged to comply with a variety of legislations and regulatory requirements. The Medical Device Regulation (MDR) regulates the placing on the market of medical devices in Europe. In order to maximize the safety for patients, users and third parties, the General Safety and Performance Requirements (Annex I) need to be fulfilled.
The compliance with the Essential Requirements are checked from the Technical File (MDR Annex II and III). Among others, the so called Harmonized Standards support the appropriate preparation of this file. These standards represent a step-by-step instruction for the corresponding application area, e.g.:
- EN 13485 for a quality management system
- EN 14971 for a risk management system
- EN 62366-1 for usability engineering
- EN 62304 for the software life cycle
- EN 60601-1 for electrical safety
- and many more
We deal with the application, interpretation, auditing and impact of such legislation.
Our self-developed simulation game “Regulatory Affairs” allows our students to learn the practical application of these theoretical contents.
Publications:
- Schudt F, Rohloff-Meinke C, Koehler N, Sohrabi K, Gross V, Scholtes M. A Comparative Overview of Digital Health Applications between Belgium and Germany. Current Directions in Biomedical Engineering. 2022;8(2): 509-511. https://doi.org/10.1515/cdbme-2022-1130.
- Seifert O, Lukas T, Sohrabi K, Gross V, Scholtes M. Evaluation of a Regulatory Orientation Guide for Young Entrepreneurs in the Field of Digital Health. Studies in Health Technology and Informatics 2022; 293: 121 – 126. doi:10.3233/SHTI220358.
- Lukas T, Sohrabi K, Gross V, Scholtes M. Health Software Product or Software as Medical Device - An Orientation Guide for Young Entrepreneurs. rrent Directions in Biomedical Engineering 2021;7(2): 644-647.
- Scholtes M, Noll K, Sohrabi K, Gross V. Comparison of Formative Evaluation Methods in the Usability Process on the Example of a Medical App. Studies in Health Technology and Informatics 2020; 271: 101 – 107. doi:10.3233/SHTI200081.
- Scholtes M, Behrend A, Buedenbender S, Gross V, Sohrabi K. Didactic Concept to Teach Regulatory Affairs by Means of a Simulation Game. Biomed. Eng.-Biomed. Tech. 2018; 63(s1): S276–S401.
- Scholtes M, Buedenbender S, Behrend A, Sohrabi K, Gross V. Integrating a Usability Engineering Process into a Consisting Risk Management. Current Directions in Biomedical Engineering 2018; 4(1): 645 – 647.
- Scholtes M, Behrend A, Buedenbender S, Gross V, Sohrabi K. Clinical Evaluation of Mobile Medical Apps. Current Directions in Biomedical Engineering 2018; 4(1): 173 – 176.
Topics for Theses:
Individual topics in the field of regulatory affairs and quality management can be elaborated.
