CARAQA - Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics
Fachhochschule Nordwestschweiz FHNW
Beschreibung des Angebots
CAS: Certificate of Advanced Studies (CAS) ist eine Nachdiplomausbildung der Hochschulen und entspricht mindestens 10 ECTS.
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.
Aufbau der Ausbildung
1 ECTS-Kreditpunkt entspricht einem Arbeitsaufwand von 25 bis 30 Arbeitsstunden.
- Introduction to the world of devices
- Course 1: Regulatory affairs, design and submissions
- Course 2: Quality Management
- Course 3: Clinical Affairs
Formal entry qualifications:
- Tertiary Educational Qualification (at least Bachelor’s level) and relevant work experience
- or Diploma HF (from a Swiss “Höhere Fachschule”) and relevant work experience As the instruction and educational materials are in English, proficiency in English (reading and writing) is a prerequisite.
Specific Admissions if the applicant does not qualify as per formal criteria above:
- At least 3 years’ work experience corresponding to or related to the relevant Continuing Education Program.
The program is aimed at people in medical device and in-vitro medical device companies (as well as subcontractors) who are facing direct or indirect challenges in a CA/RA/QA environment.
- 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
CAS FHNW in Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics
Ort / Adresse
- Muttenz (BL)
26 days over 6 months
In collaboration with Medidee, the School of Life Sciences FHNW offers a unique training opportunity for Medtech professionals facing the current major regulatory challenges. The CAS-Program fulfils the requirements of article 15 of MDR / IVDR.
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