المؤلفون: Francesco Giacobbe, Elisabetta Bemporad, Alberto Carro, Fabio Pera

المصدر: International Journal for Quality Research, Vol 18, Iss 1, Pp 153-166 (2024)

مصطلحات موضوعية: ce marking, directive ped, hls high level structure, iso 9001:2015, pressure equipment, quality management system, risk based thinking, Management. Industrial management, HD28-70

وصف الملف: electronic resource

العلاقة: http://ijqr.net/journal/v18-n1/10.pdfTest; https://doaj.org/toc/1800-6450Test; https://doaj.org/toc/1800-7473Test

الوصول الحر: https://doaj.org/article/5471df4361f64dc69c78e16e6840922eTest

المؤلفون: Pazart, Lionel, Armbruster, Vincent, Monin, Debora, Mehrkens, Jan-Hinnerk, Borel, Monique, Nihouannen, Damien, Barbot, Frédéric, Bouquet, Fabrice, Carrault, Guy, Lihoreau, Thomas, Durand, Marlène, Clogenson, Helène, Pelayo, Sylvia

المساهمون: Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté COMUE (UBFC), Centre d'Investigation Clinique de Besançon (Inserm CIC 1431), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang Bourgogne-Franche-Comté (EFS BFC)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté COMUE (UBFC)-Université Bourgogne Franche-Comté COMUE (UBFC), Université de Bordeaux (UB), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Franche-Comté Électronique Mécanique, Thermique et Optique - Sciences et Technologies (UMR 6174) (FEMTO-ST), Université de Technologie de Belfort-Montbeliard (UTBM)-Ecole Nationale Supérieure de Mécanique et des Microtechniques (ENSMM)-Centre National de la Recherche Scientifique (CNRS)-Université de Franche-Comté (UFC), Centre Hospitalier Universitaire Rennes, Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'Investigation Clinique Rennes (CIC), Université de Rennes (UR)-Centre Hospitalier Universitaire de Rennes CHU Rennes = Rennes University Hospital Ponchaillou -Institut National de la Santé et de la Recherche Médicale (INSERM), French-Clinical Research Infrastructure Network - F-CRIN Paris (Cardiovascular & Renal Clinical Trialists - CRCT ), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille), Evaluation des technologies de santé et des pratiques médicales - ULR 2694 (METRICS), Université de Lille-Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille), Centre d'Investigation Clinique - Innovation Technologique de Lille - CIC 1403 - CIC 9301 (CIC Lille), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille)

المصدر: Special Session on European Regulations for Medical Devices: What Are the Lessons Learned after 1 Year of Implementation? ; https://hal.science/hal-04501305Test ; Special Session on European Regulations for Medical Devices: What Are the Lessons Learned after 1 Year of Implementation?, Feb 2024, Rome, Italy. ⟨10.5220/0012593900003657⟩

مصطلحات موضوعية: CE Marking, Skills-Based Approach, MDR, IVDR, Training, Regulatory Affairs, Clinical Investigation, Medical Device, [SDV.IB]Life Sciences [q-bio]/Bioengineering

جغرافية الموضوع: Rome, Italy

العلاقة: hal-04501305; https://hal.science/hal-04501305Test; https://hal.science/hal-04501305/documentTest; https://hal.science/hal-04501305/file/125939.pdfTest

الإتاحة: https://doi.org/10.5220/0012593900003657Test
https://hal.science/hal-04501305Test
https://hal.science/hal-04501305/documentTest
https://hal.science/hal-04501305/file/125939.pdfTest

المؤلفون: Frank Hulstaert, Céline Pouppez, Célia Primus-de Jong, Kathleen Harkin, Mattias Neyt

المصدر: Orphanet Journal of Rare Diseases, Vol 18, Iss 1, Pp 1-13 (2023)

مصطلحات موضوعية: Medical devices, Evidence gaps, CE marking, Reimbursement, Declaration of Helsinki, Comparator, Medicine

وصف الملف: electronic resource

العلاقة: https://doaj.org/toc/1750-1172Test

الوصول الحر: https://doaj.org/article/604e469d17d24aad963354bd229ab9d6Test

المؤلفون: Marques, Bruno Oliveira

المساهمون: Silva, João Pedro Mendonça de Assunção da, Universidade do Minho

مصطلحات موضوعية: Marcação CE, Nivelador de cais, Diretiva máquinas, Análise de riscos, CE marking, Dock leveler, Machine directive, Risk assessment, Engenharia e Tecnologia::Engenharia Mecânica

وصف الملف: application/pdf

العلاقة: 203087976

الإتاحة: https://hdl.handle.net/1822/82153Test

المؤلفون: S, NAGA SWAROOPA, K, VENKATESWARA RAJU, NL, PRASANTHI

المصدر: Asian Journal of Pharmaceutical and Clinical Research; Vol 16 Issue 3 March 2023; 6-14 ; 2455-3891 ; 0974-2441

مصطلحات موضوعية: MDR, MDD, Pre-market notification, NB, CE marking

وصف الملف: application/pdf

العلاقة: https://innovareacademics.in/journals/index.php/ajpcr/article/view/46624/27817Test; https://innovareacademics.in/journals/index.php/ajpcr/article/view/46624Test

الإتاحة: https://innovareacademics.in/journals/index.php/ajpcr/article/view/46624Test

المؤلفون: Almeida, Ana Catarina Correia

المساهمون: Lopes, Duarte Barroso, Repositório Científico do Instituto Politécnico do Porto

مصطلحات موضوعية: Controlo de Produção em Fábrica, EN 16034, Marcação CE, Porta Corta-Fogo, Factory production control, CE Marking, Fire-door

وصف الملف: application/pdf

الإتاحة: http://hdl.handle.net/10400.22/18193Test

المؤلفون: Pereira, A. B., Martinho, J. C. F., Silva, F. J. G.

المساهمون: Repositório Científico do Instituto Politécnico do Porto

مصطلحات موضوعية: Under Pressure Equipment, Boiler, Welding, Requirements, Specification, Procedure, Welder, CE Marking, Quality, Control

وصف الملف: application/pdf

العلاقة: 978-1-53619-685-6

الإتاحة: http://hdl.handle.net/10400.22/18042Test

المؤلفون: Pemberton, J. S., Wilmot, E. G., Barnard-Kelly, K., Leelarathna, L., Oliver, N., Randell, T., Taplin, C. E., Choudhary, P., Adolfsson, Peter, 1963

المصدر: Diabetes Obesity & Metabolism. 25(4):916-939

مصطلحات موضوعية: Endocrinology and Diabetes, Endokrinologi och diabetes, accuracy, CE marking, continuous glucose monitoring (CGM), type 1, diabetes, type 2 diabetes, hybrid closed-loop, glucose monitoring-system, insulin delivery, adults, multicenter, performance, adolescents, management, consensus, children, Endocrinology & Metabolism

الوصول الحر: https://gup.ub.gu.se/publication/326390Test

المؤلفون: Michelin, Linus, Cantillana, Emilia

مصطلحات موضوعية: SwiftVitals, medical technology, material selection, manufacturing methods, CE marking, electromagnetic compatibility (EMC), polymers, mass production, product design, medicinteknik, materialval, tillverkningsmetoder, CE-märkning, EMC, polymerer, serieproduktion, produktdesign, Medical Equipment Engineering, Medicinsk apparatteknik

وصف الملف: application/pdf

العلاقة: TRITA-CBH-GRU ; 2024:190

الإتاحة: http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-349215Test

المؤلفون: Almpani Sofia, Mitsikas Theodoros, Stefaneas Petros, Frangos Panayiotis

المصدر: Paladyn, Vol 11, Iss 1, Pp 414-427 (2020)

مصطلحات موضوعية: wearable robots, exoskeletons, conformity assessment, ce marking, psoa ruleml, Technology

وصف الملف: electronic resource

العلاقة: https://doaj.org/toc/2081-4836Test

الوصول الحر: https://doaj.org/article/8209d4052ab04adfbe70f8b305215215Test