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CAS CARAQA

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

Key data

Degree
CAS FHNW in Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics
ECTS points
13
Next start
January 2022. More detailed info to follow.
Teaching language
English
Place
FHNW Campus Muttenz
Price
CHF 8’800 (including examination fees)

Information events

Oct 21, 2021 06:00 PM, Campus Muttenz Info Event CAS CARAQA

Registration

CAS CARAQA ‘22 will start in January next year. Detailed information can be obtained at our information events. More information please find in the sidebar.

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.

Supported by
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The Swiss Medtech and In-Vitro Diagnostic industries are facing a dynamic and highly challenging situation. On May 26th 2021 the Medical Device Regulation (MDR) became the only regulation applied to medical device manufacturers throughout Europe; major changes and new requirements were introduced. For the diagnostics world, this change is on the horizon as well; from May 26th 2022 the In-Vitro Diagnostic Medical Device Regulation (IVDR) will fully apply. Additionally, the Swiss Federal Government has decided to terminate negotiations on the EU-Swiss Institutional Framework Agreement. As a direct consequence, the Mutual Recognition Agreement is not being updated, forcing Swiss companies to act as if from a third country and establish European Representatives in order to access the European market.

CAS CARAQA: Clinical, Regulatory and Quality Affairs for Medical Devices & In-Vitro Diagnostics
To support and strengthen the economic power of this sector, access to this most important market has to be assured, and Swiss manufacturers must be well prepared for the new requirements in the MDR and IVDR regulatory landscape. To train and empower professionals involved in quality, regulatory or clinical affairs to handle these challenges, the FHNW School of Life Sciences and Medidee®, supported by Swiss Medtech, offer the CAS CARAQA program – the Certificate of Advanced Studies in Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics (CAS CARAQA). 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 the responsibility within their company for regulatory compliance (PRRC) according to Art. 15 MDR and IVDR.
Already more than 100 participants have successfully followed CARAQA in Muttenz, Yverdon-Les-Bains, Louvain-La-Neuve in Belgium.

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Overview

Contact

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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
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