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

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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The pandemic situation in 2020 is a challenge for people, organizations and industries around the world. To prevent shortages or delays in getting key medical equipment onto the European market, the EU have postponed application of the Medical Devices Regulation until May 26th, 2021. For Swiss medical device manufacturers this decision comes with extension of direct access to the European market, postponing EU “third country” status for a year. Nevertheless, given the referendum on free movement of citizens from the EU in September, and the lack of an update for the mutual recognition agreement, Swiss medical device manufacturers are still facing serious threats.

Therefore, being well prepared for the changes in the regulatory landscape remains vitally important for all manufacturers. Professionals playing major roles in quality, regulatory or clinical affairs need to be well prepared to face these challenges. To develop and enhance this knowledge and combine it with hands-on experience, the School of Life Sciences FHNW and Medidee® offer a unique training opportunity: the Certificate of Advanced Studies in Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics (CAS CARAQA), supported by Swiss Medtech. Experienced professionals from medical and in-vitro medical device manufacturers will share their insights and experience. They will empower participants with advanced knowledge and provide them with a broad range of skills to take duty as a person responsible for regulatory compliance (PRRC) according Art. 15 MDR and IVDR within their company.

The CAS CARAQA ‘21 will start in January next year. Detailed information can be obtained at the info event on September 8th or October 15th 2020 at 18:00 online or at FHNW Campus Muttenz.




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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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