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1Academic Journal
المؤلفون: A. Dobrzynska, J. C. Rejon-Parrilla, D. Epstein, J. Aranda-López, A. G. Fraser, J. A. Blasco-Amaro
المصدر: Frontiers in Medical Technology, Vol 7 (2025)
مصطلحات موضوعية: certificates of conformity, conditional approval, high-risk medical devices, Notified Bodies, Medical Device Regulation 2017/745, Medical technology, R855-855.5
وصف الملف: electronic resource
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2Academic Journal
المؤلفون: Breda Kearney, Olivia McDermott
المصدر: Cogent Engineering, Vol 10, Iss 2 (2023)
مصطلحات موضوعية: Medical Device Regulations (MDR), Europe, EMA, European medicines agency, notified bodies, clinical trials, Engineering (General). Civil engineering (General), TA1-2040
وصف الملف: electronic resource
Relation: https://doaj.org/toc/2331-1916
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3Academic Journal
المؤلفون: Pappalardo F., Wilkinson J., Busquet F., Bril A., Palmer M., Walker B., Curreli C., Russo G., Marchal T., Toschi E., Alessandrello R., Costignola V., Klingmann I., Contin M., Staumont B., Woiczinski M., Kaddick C., Salvatore V. D., Aldieri A., Geris L., Viceconti M.
المساهمون: Pappalardo F., Wilkinson J., Busquet F., Bril A., Palmer M., Walker B., Curreli C., Russo G., Marchal T., Toschi E., Alessandrello R., Costignola V., Klingmann I., Contin M., Staumont B., Woiczinski M., Kaddick C., Salvatore V.D., Aldieri A., Geris L., Viceconti M.
مصطلحات موضوعية: Medical devices, In Silico Trials, Regulatory System, Notified Bodies
وصف الملف: ELETTRONICO
Relation: info:eu-repo/semantics/altIdentifier/pmid/35951559; info:eu-repo/semantics/altIdentifier/wos/WOS:000882005700005; volume:26; issue:11; firstpage:5282; lastpage:5286; numberofpages:5; journal:IEEE JOURNAL OF BIOMEDICAL AND HEALTH INFORMATICS; info:eu-repo/grantAgreement/EC/H2020/77712; https://hdl.handle.net/11585/893827; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85136906841; https://ieeexplore.ieee.org/document/9855387
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4Academic Journal
المؤلفون: Peter Fennema, Hassan Achakri
المصدر: AboutOpen, Vol 8, Iss 1 (2021)
مصطلحات موضوعية: MDR, Medical devices, Compliance, Notified Bodies, Medicine
وصف الملف: electronic resource
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5Academic Journal
المؤلفون: Bhavyasri, D., Manikandan, K., Kamaraj, R.1
المصدر: Research Journal of Pharmacy and Technology 12(1):391-395. 2019
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المؤلفون: Francesco Pappalardo, John Wilkinson, Francois Busquet, Antoine Bril, Mark Palmer, Barry Walker, Cristina Curreli, Giulia Russo, Thierry Marchal, Elena Toschi, Rossana Alessandrello, Vincenzo Costignola, Ingrid Klingmann, Martina Contin, Bernard Staumont, Matthias Woiczinski, Christian Kaddick, Valentina Di Salvatore, Alessandra Aldieri, Liesbet Geris, Marco Viceconti
المساهمون: Pappalardo F., Wilkinson J., Busquet F., Bril A., Palmer M., Walker B., Curreli C., Russo G., Marchal T., Toschi E., Alessandrello R., Costignola V., Klingmann I., Contin M., Staumont B., Woiczinski M., Kaddick C., Salvatore V.D., Aldieri A., Geris L., Viceconti M.
المصدر: IEEE Journal of Biomedical and Health Informatics. 26:5282-5286
مصطلحات موضوعية: notified bodies, Technology, Regulatory System, Notified Bodies, Health Informatics, Medical devices, In Silico Trials, Regulatory System, Notified Bodies, Health Information Management, Animals, Electrical and Electronic Engineering, In Silico Trials, in Silico Trials, Science & Technology, Computer Science, Information Systems, Biological system modeling, Drugs, Computational modeling, regulatory system, Europe, Medical devices, Safety, Computer Science Applications, Computer Science, Computer Science, Interdisciplinary Applications, Mathematical & Computational Biology, Life Sciences & Biomedicine, Medical Informatics
وصف الملف: ELETTRONICO; Print-Electronic
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7Academic 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 2021 , ' Implementation of the new EU IVD regulation - urgent initiatives are needed to avert impending crisis ' , Clinical Chemistry and Laboratory Medicine . https://doi.org/10.1515/cclm-2021-0975
مصطلحات موضوعية: CE-IVD tests, competent authorities, in-house developed tests, European Commission, IVDR 2017/746, notified bodies, expert panel, EU regulatory system for IVDR implementation
وصف الملف: application/pdf
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8Conference
المؤلفون: Frankel, Christian, Galland, Jean-Pierre
المساهمون: Copenhagen Business School Copenhagen (CBS), Laboratoire Techniques, Territoires et Sociétés (LATTS), Université Paris-Est Marne-la-Vallée (UPEM)-École nationale des ponts et chaussées (ENPC)-Centre National de la Recherche Scientifique (CNRS), EURAS, K.B. Skriver, K. Jacobs, J.Jerlang
المصدر: 20th EURAS Annual Standardization Conference
https://enpc.hal.science/hal-01275604
20th EURAS Annual Standardization Conference, EURAS, Jun 2015, Copenhagen, Denmarkمصطلحات موضوعية: New Approach on Standardization, Notified Bodies, Single Market, Medical Devices, PIP affair, [SHS.SOCIO]Humanities and Social Sciences/Sociology
جغرافية الموضوع: Copenhagen, Denmark
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9Academic 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 -
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مصطلحات موضوعية: notified bodies, competent authorities, European Com-mission, EU regu-latory system for IVDR implementation, in-house developed tests, IVDR 2017, CE-IVD tests, expert panel
وصف الملف: application/pdf
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11Academic Journal
المؤلفون: Enzmann, Harald, Meyer, Ralf, Broich, Karl
المصدر: Biomarkers in medicine, 10:12:261–1268
مصطلحات موضوعية: CE mark, certification, notified bodies, companion diagnostics, conformity, regulation, in vitro diagnostics, marketing authorisation, benefit-risk balance, medical devices
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المؤلفون: Francesca Pedrielli
المصدر: pp.1–8, 2021
مصطلحات موضوعية: notified bodies, organismi notificati, 2000/14/EC, 2000/14/CE
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13Dissertation/ Thesis
المؤلفون: Qi, Jianing, Wei, Shilun
مصطلحات موضوعية: Medical device regulation, Notified Bodies, Additive Manufacturing, Additive Manufacturing in healthcare, Engineering and Technology, Teknik och teknologier
وصف الملف: application/pdf
Relation: SAMINT-MILI ; 20037
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14
المؤلفون: Pedrielli Francesca
المصدر: pp.1–58, 2020
مصطلحات موضوعية: Directive 2000/14/EC, notified bodies
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15
المؤلفون: Pedrielli Francesca
المصدر: pp.1–48, 2020
مصطلحات موضوعية: Directive 2000/14/EC, notified bodies
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16
المؤلفون: Gail A. Van Norman
المصدر: JACC: Basic to Translational Science
JACC: Basic to Translational Science, Vol 1, Iss 5, Pp 399-412 (2016)مصطلحات موضوعية: lcsh:Diseases of the circulatory (Cardiovascular) system, Device Approval, CE, Conformité Européenne, 030204 cardiovascular system & hematology, Public administration, NB, Notified Bodies, Food and drug administration, 03 medical and health sciences, 0302 clinical medicine, drug approval, EMA, Political science, EU, European Union, Agency (sociology), TRANSLATIONAL TOOLBOX, media_common.cataloged_instance, European commission, 030212 general & internal medicine, European union, European Commission, media_common, device approval, Member states, BMJ, British Medical Journal, Consumer protection, FDA, Food and Drug Administration, Innovative Therapies, DAD, drugs and devices, lcsh:RC666-701, MHRA, Medicines and Healthcare Products Regulatory Agency, EMA, European Medicines Agency, EC, European Commission, Cardiology and Cardiovascular Medicine, PMA, pre-market approval, FDA
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17
المؤلفون: Pedrielli Francesca
المصدر: pp.1–61, 2019
مصطلحات موضوعية: Directive 2000/14/EC, notified bodies
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18
المؤلفون: Pedrielli Francesca
المصدر: pp.1–8, 2019
مصطلحات موضوعية: Directive 2000/14/EC, notified bodies
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19
المؤلفون: Klarić, Anto
المساهمون: Dolaček-Alduk, Zlata, Krstić, Hrvoje, Miličević, Ivana
مصطلحات موضوعية: notified bodies, izjava o svojstvima, tvornička kontrola proizvodnje, ocjenjivanje i provjera stalnosti svojstava, tijelo za tehničko ocjenjivanje, prijavljena tijela, tehchnical assessment body, factory production control, declaration of performance, assessment and verification of constancy of perfomance
وصف الملف: application/pdf
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20Periodical
المؤلفون: Fangrat, J., Maciejak, P.
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