Description de la formation

CAS: Certificate of Advanced Studies (CAS) ist eine Nachdiplomausbildung der Hochschulen und entspricht mindestens 10 ECTS.

The MedTech sector in Europe is grappling with the challenges posed by the Medical Device Regulation (EU 2017/745, MDR) and the In-Vitro Diagnostic Device Regulation (EU 2017/746, IVDR). The transition to the regulations in 2021 for medical devices and in 2022 for in-vitro diagnostics is still underway, creating additional burdens for certifying novel and existing devices. Swiss companies in particular are facing more difficulties as the Mutual Recognition Agreement has not been updated. This forces those firms into third country status, creating the need to establish European Representatives for the EU market, while implementing the "Swiss Finish" of the MDR and IVDR for the domestic market.

To strengthen and maintain the economic impact of this sector through professional development and empowerment of its members, Veranex and the FHNW School of Life Sciences offer the Certificate of Advanced Studies in Clinical, Regulatory, and Quality affairs for Medical Devices and In-Vitro Diagnostics - CAS CARAQA.

This program is designed for regulatory, clinical and quality experts in the MedTech world. Our continuing education programme provides participants with advanced knowledge, hands-on experience and first-hand skills from experts in the industry. The course structure enables participants to assume responsibility for regulatory compliance (PRRC) in accordance with Art. 15 MDR and IVDR within their organisation. With the evolving landscape of CA, RA and QA functions, our aim is to develop a diverse range of technical and soft skills. This will enable professionals to make key organisational decisions and play a vital role in maintaining the competitiveness and longevity of the company. The program provides in-depth insights into regulatory, clinical and quality management aspects, emphasising the application of this knowledge in a practical professional context.

CAS CARAQA in Muttenz is part of the European CARAQA network. To date, more than 150 participants have successfully completed CARAQA in Muttenz, Yverdon-Les-Bains, Lubeck and Louvain-La-Neuve in Belgium.

The CAS CARAQA develops the following skills:

• Optimal preparation for MDR 2017/745 and IVDR 2017/746 regulatory changes
• Strategic planning and management of clinical evaluations, investigations under ISO 14155 and IVD performance studies
• Strategic and tactical communication for interaction with Notified Bodies and National Competent Authorities, and for dealing with crisis situations
• Management and engineering support during new product development projects
• Leadership in the deployment and maintenance of Quality Management Systems under ISO 13485 and US QSR
• Structuring of supply chain, production and marketing
• Technical expertise in key subjects such as risk management, biocompatibility, usability and software validation, according to current standards

Plan de la formation

13 ECTS-Punkte

1 ECTS-Kreditpunkt entspricht einem Arbeitsaufwand von 25 bis 30 Arbeitsstunden.

Program Structure

The CARAQA training is structured around three main pillars: Clinical Affairs, Regulatory Affairs and Quality Assurance - CA/RA/QA. As this landscape is still very dynamic and the requirements set by the European Commission are constantly evolving, the content of the program will be continuously adapted to reflect the current needs and challenges of the MedTech industry.

• Introduction to the world of Medical Devices and In-Vitro Diagnostics
• Course 1: Regulatory Affairs
• Course 2: Quality Management
• Course 3: Clinical Affairs