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The European Medical Device and In-Vitro Diagnostic Medical Device industry is currently facing a highly challenging situation, as applied regulations have changed significantly over the last year. To cope with this, a novel continuing education program for employees from these sectors provides knowledge and hands-on experience in clinical, regulatory and quality affairs. Since 2020 two classes have been successfully completed at the University of Applied Sciences and Arts Northwestern Switzerland: this paper describes the concept and content, the students, and the benefits both for participants and their employers.

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http://dx.doi.org/10.1109/EMBC48229.2022.9871082DOI Listing

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