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

Key data

CAS FHNW in Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics
ECTS points
Next start
Jan 09, 2024
Final application date
Oct 31, 2023
Teaching language
FHNW Campus Muttenz
CHF 8’800 (including examination fees)

CAS CARAQA ‘24 will start in January next year. Detailed information can be obtained at our information events. More information please find in the info box above.

In collaboration with Medidee®, the FHNW School of Life Sciences offers a unique training opportunity for Medtech professionals facing the current major changes in regulations. This program delivers detailed insights into regulatory, clinical affairs and quality management for Medical Devices and In Vitro Diagnostics, combined with hands-on experience from experts on how to adopt and apply this knowledge in your professional context.

The European Medical Device and In-Vitro Diagnostic Medical Device industry is facing serious challenges due to recent significant changes in regulations. Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Device Regulation (IVDR) have become the sole European regulations, increasing the burden on stakeholders in the Medical Device sector. Con-verting to MDR or IVDR is currently firms’ greatest challenge, along with increased documentation requirements, higher barriers and longer market approval times. Swiss companies are facing even more challenges, as the EU/CH Mutual Recognition Agreement has not been up-dated, forcing Swiss companies to act as a third country and establish European Representatives for the EU market, while applying the “Swiss Finish” of the MDR and IVDR for the domestic market.

The CAS CARAQA is designed to support and strengthen the economic power of this sector by training and empowering professionals involved in quality, regulatory or clinical affairs to handle these challenges. The FHNW School of Life Sciences and Medidee® offer the CAS CARAQA program – the Certificate of Advanced Studies in Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics. This continuing education program offers participants advanced knowledge, hands-on experience and applied skills at first-hand from experts in the medical and in-vitro diagnostic medical device industry. The program is designed to enable participants to take on responsibility within their organisation for regulatory compliance (PRRC) according to Art. 15 MDR and IVDR.

CAS CARAQA in Muttenz is part of the European CARAQA network. So far more than 100 participants have successfully completed CARAQA in Muttenz, Yverdon-Les-Bains and Lou-vain-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