Search Results - Vanstapel, Florent
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Urgent call to the European Commission to simplify and contextualize IVDR Article 5.5 for tailored and precision diagnostics: opinion paper by Cobbaert, Christa (Author) , Schweiger, Christian (Author) , Buchta, Christoph (Author) , Streichert, Thomas (Author) , Vanstapel, Florent (Author) , Mullier, Francois (Author) , Biaggini, Lucas (Author) , Capoluongo, Ettore (Author) , Bossuyt, Patrick (Author) , Bhattoa, Harjit Pal (Author) , Melvin, Tom (Author) , Neumaier, Michael (Author) ,
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ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro-Diagnostics... by Vanstapel, Florent (Author) , Orth, Matthias (Author) , Streichert, Thomas (Author) , Capoluongo, Ettore D. (Author) , Oosterhuis, Wytze P. (Author) , Çubukçu, Hikmet Can (Author) , Bernabeu-Andreu, Francisco A. (Author) , Thelen, Marc (Author) , Jacobs, Leo H. J. (Author) , Linko, Solveig (Author) , Bhattoa, Harjit Pal (Author) , Bossuyt, Patrick M. M. (Author) , Brguljan, Pika Meško (Author) , Boursier, Guilaine (Author) , Cobbaert, Christa (Author) , Neumaier, Michael (Author) ,
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Implementation of the new EU IVD regulation: urgent initiatives are needed to avert impending crisis by Cobbaert, Christa (Author) , Capoluongo, Ettore D. (Author) , Vanstapel, Florent (Author) , Bossuyt, Patrick M. M. (Author) , Bhattoa, Harjit Pal (Author) , Nissen, Peter Henrik (Author) , Orth, Matthias (Author) , Streichert, Thomas (Author) , Young, Ian S. (Author) , Macintyre, Elizabeth (Author) , Fraser, Alan G. (Author) , Neumaier, Michael (Author) ,
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Related Subjects
European Commission
CE-IVD tests
EU regulatory system for IVDR implementation
European Regulation 2017/746 on In-Vitro-Diagnostic Devices
IH-IVDs
ISO 15189:2012
IVDR 2017/746
IVDR Article 5.5
competent authorities
disproportionate regulation
expert panel
in-house developed tests
laboratory-developed tests for in-house use
method validation
notified bodies
precision diagnostics