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Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics

Key data

CAS Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics
ECTS points
Next start
Tue, 7.1.2025
Final application date
Fri, 18.10.2024
Teaching language
FHNW Campus Muttenz
CHF 8’800 (including examination fees)

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.





Heads of Program

Training Managers

FHNW School of Life Sciences

FHNW University of Applied Sciences and Arts Northwestern Switzerland School of Life Sciences Hofackerstrasse 30 CH - 4132 Muttenz
More information about the location