MDR: University trains experts for regulatory issues
The legal requirements for market access to medical technology products vary worldwide and pose high professional demands. Pforzheim University of Applied Sciences (HSPF), with support from the Richard and Annemarie Wolf Foundation, has now founded the Center for Market Access and Regulatory Affairs to support industry companies with these challenges. The centre of excellence is in the university's Faculty of Technology.
Regulations diverge worldwideToday, market access for medical products requires strategic and communicative skills as well as expert knowledge of legal contexts, because regulatory provisions are increasingly diverging around the globe. This is reflected in the courses offered. According to Andrea Völker, Head of Department Senior Executive Consultant Health Care Policy and Relations at Richard Wolf GmbH, the aim of the course "International Licensing" is to provide the basic tools to acquire these skills. Völker was involved in setting up the new centre of excellence and teaches as a lecturer at Pforzheim University.
Max Barchet is also active in teaching. The laboratory manager and lecturer in the competence centre gives an outlook: "I will not only teach the students the safety concepts and standards of medical electrical equipment (ME equipment) theoretically in the lecture hall, but will also give the students the opportunity to experience the concepts practically in the laboratory and to carry out the necessary measurements themselves," Barchet reports.
Thanks to the centre of excellence, we can offer students a comprehensive range of courses in the areas of approval, quality management and safety testing in medical technology, which is unique in Germany. Due to the far-reaching legal changes brought about by the MDR, there is a high demand in the industry for graduates who have acquired extensive knowledge in these areas.