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1Academic Journal
المؤلفون: Cobbaert, Christa, Capoluongo, Ettore D., Vanstapel, Florent J.L.A., Bossuyt, Patrick M.M., Bhattoa, Harjit Pal, Nissen, Peter Henrik, Orth, Matthias, Streichert, Thomas, Young, Ian S., Macintyre, Elizabeth, Fraser, Alan G., Neumaier, Michael
المصدر: Clinical Chemistry and Laboratory Medicine (CCLM) ; volume 60, issue 1, page 33-43 ; ISSN 1434-6621 1437-4331
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2Academic Journal
المؤلفون: Vanstapel, Florent J.L.A., Orth, Matthias, Streichert, Thomas, Capoluongo, Ettore D., Oosterhuis, Wytze P., Çubukçu, Hikmet Can, Bernabeu-Andreu, Francisco A., Thelen, Marc, Jacobs, Leo H.J., Linko, Solveig, Bhattoa, Harjit Pal, Bossuyt, Patrick M.M., Meško Brguljan, Pika, Boursier, Guilaine, Cobbaert, Christa M., Neumaier, Michael
المصدر: Clinical Chemistry and Laboratory Medicine (CCLM) ; volume 61, issue 4, page 608-626 ; ISSN 1434-6621 1437-4331
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3Academic Journal
المصدر: Clinical Chemistry and Laboratory Medicine (CCLM) ; volume 62, issue 1, page e1-e3 ; ISSN 1434-6621 1437-4331
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4Academic JournalIn-house diagnostic devices under the EU IVDR and unwanted side-effects of intentional transparency.
المصدر: Clinical Chemistry & Laboratory Medicine; Jan2024, Vol. 62 Issue 1, pe1-e3, 3p
مصطلحات موضوعية: MEDICAL equipment, TRANSLATIONAL research, QUALITY assurance, PATIENT care
الشركة/الكيان: EUROPEAN Commission
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5Academic Journal
المؤلفون: Cobbaert, Christa, Capoluongo, Ettore D., Vanstapel, Florent J.L.A., Bossuyt, Patrick M.M., Bhattoa, Harjit Pal, Nissen, Peter Henrik, Orth, Matthias, Streichert, Thomas, Young, Ian S., MacIntyre, Elizabeth, Fraser, Alan G., Neumaier, Michael
المصدر: Cobbaert , C , Capoluongo , E D , Vanstapel , F J L A , Bossuyt , P M M , Bhattoa , H P , Nissen , P H , Orth , M , Streichert , T , Young , I S , MacIntyre , E , Fraser , A G & Neumaier , M 2022 , ' Implementation of the new EU IVD regulation-urgent initiatives are needed to avert impending crisis ' , Clinical Chemistry and Laboratory Medicine , vol. 60 , no. 1 , pp. 33-43 . https://doi.org/10.1515/cclm-2021-0975
مصطلحات موضوعية: CE-IVD tests, competent authorities, EU regulatory system for IVDR implementation, European Commission, expert panel, in-house developed tests, IVDR 2017/746, notified bodies, scipo, droit
Relation: https://pure.au.dk/ws/files/331557534/10.1515_cclm_2021_0975.pdf; https://pure.au.dk/portal/da/publications/implementation-of-the-new-eu-ivd-regulationurgent-initiatives-are-needed-to-avert-impending-crisis(343594c7-618d-40c3-84e5-846bea79ffe4).html
الاتاحة: https://pure.au.dk/ws/files/331557534/10.1515_cclm_2021_0975.pdf
https://pure.au.dk/portal/da/publications/implementation-of-the-new-eu-ivd-regulationurgent-initiatives-are-needed-to-avert-impending-crisis(343594c7-618d-40c3-84e5-846bea79ffe4).html -
6Academic Journal
المؤلفون: Henny, Joseph, Vassault, Anne, Boursier, Guilaine, Vukasovic, Ines, Brguljan, Pika Mesko, Lohmander, Maria, Ghita, Irina, Andreu, Francisco A. Bernabeu, Kroupis, Christos, Sprongl, Ludek, Thelen, Marc H.M., Vanstapel, Florent J.L.A., Vodnik, Tatjana, Huisman, Willem, Vaubourdolle, Michel
المصدر: Clinical Chemistry and Laboratory Medicine (CCLM) ; volume 55, issue 3 ; ISSN 1437-4331 1434-6621
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7Academic Journal
المؤلفون: Henny, Joseph, Vassault, Anne, Boursier, Guilaine, Vukasovic, Ines, Mesko Brguljan, Pika, Lohmander, Maria, Ghita, Irina, Andreu, Francisco A. Bernabeu, Kroupis, Christos, Sprongl, Ludek, Thelen, Marc H.M., Vanstapel, Florent J.L.A., Vodnik, Tatjana, Huisman, Willem, Vaubourdolle, Michel
المصدر: Clinical Chemistry and Laboratory Medicine (CCLM) ; volume 54, issue 12, page 1893-1900 ; ISSN 1437-4331 1434-6621
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8Academic Journal
المؤلفون: Thelen, Marc H.M., Vanstapel, Florent J.L.A., Kroupis, Christos, Vukasovic, Ines, Boursier, Guilaime, Barrett, Edward, Andreu, Francisco Bernabeu, Brguljan, Pika Meško, Brugnoni, Duilio, Lohmander, Maria, Sprongl, Ludek, Vodnik, Tatjana, Ghita, Irina, Vaubourdolle, Michel, Huisman, Willem, on behalf of the Working Group Accr
المصدر: Clinical Chemistry and Laboratory Medicine (CCLM) ; volume 53, issue 8 ; ISSN 1437-4331 1434-6621