The «Certificate of Advanced Studies in Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostic» (CAS CARAQA) offers a unique training opportunity for Medtech professionals facing the current major regulatory challenges.
The adoption of the new European regulation on medical devices and in vitro diagnostic requires serious adaptations in the Medtech sector, and most notably the involvement of a «Qualified Person» within the company itself. These changes result in major pressure on the employees in charge of activities including Clinical Affairs, Regulatory Affairs and Quality Assurance. Countries in the Gulf, Asia and South America now have requirements that are as complex as those in Europe or the USA. Exporting to these countries is therefore a challenge for Swiss firms. The CAS-Programme fulfils the requirements of article 15 of MDR / IVDR.
The training involves the development of a wide range of technical and human skills to become the company's decision-making centres and play a key role in maintaining the company's competitiveness and sustainability in the face of development.
This includes optimal preparation for regulatory changes with MDR 2017/745 and IVDR 2017/746, strategic, tactical and communication skills in crisis situations and interaction difficulties with Notified Bodies and authorities, management skills around production and marketing processes for new medical devices, technical expertise in key issues such as biocompatibility, usability, clinical testing and evaluation, software validation, management support in new product development.
Employees in the regulatory, clinical and / or quality assurance department
Engineers from electronics, mechanical or software disciplines, in charge of medical device or in-vitro medical device projects
Experts in manufacturing and production
Physicians, scientists or inventors of medical products
Laboratory assistants involved in the development of new analytical methods or process automation
Employees involved in clinical studies or quality/ regulatory processes in a healthcare organization
Certificate of Advanced Studies (CAS) – ECTS points: 13
The English training program is offered by two Swiss institutions: the «Haute Ecole d'Ingénierie et de Gestion du Canton de Vaud» (HEIG-VD) in Yverdon-les-Bains and the «School of Life Sciences (Fachhochschule Nordwestschweiz/FHNW)» in Muttenz.
Muttenz next to Basel
Hochschule für Life Sciences
Heads of Programme
Prof. Dr. David Hradetzky
+41 61 228 54 58
Dr. Elena Lucano
Medidee Services SA
+41 76 270 37 51