المؤلفون: McGrane, Vincent, McDermott, Olivia, Trubetskaya, Anna, Rosa, Angelo, Sony, Michael

مصطلحات موضوعية: continuous improvement, medical device, MedTech, Lean Six Sigma, ISO 13485, 21CFR 820, validation

وصف الملف: application/pdf

Relation: Processes; McGrane, Vincent, McDermott, Olivia, Trubetskaya, Anna, Rosa, Angelo, & Sony, Michael. (2022). The Effect of Medical Device Regulations on Deploying a Lean Six Sigma Project. Processes, 10(11). doi:10.3390/pr10112303; http://hdl.handle.net/10379/17871; https://doi.org/10.3390/pr10112303

الاتاحة: http://hdl.handle.net/10379/17871
https://doi.org/10.3390/pr10112303

المؤلفون: Javier Ramos Ramos, Alix Fernanda Cañaveral Rodríguez, Hernando Camacho Camacho

المصدر: Signos, Vol 13, Iss 2, Pp 48-78 (2021)

مصطلحات موضوعية: sistema de gestión, iso 13485, dispositivos médicos, calidad, eficacia, Business, HF5001-6182

وصف الملف: electronic resource

Relation: https://revistas.usantotomas.edu.co/index.php/signos/article/view/6663; https://doaj.org/toc/2145-1389

URL الوصول: https://doaj.org/article/be83d87ad8314add8d4a06971f668390

المؤلفون: Urszula Mentel, Marzena Hajduk-Stelmachowicz

المصدر: Problems and Perspectives in Management, Vol 18, Iss 4, Pp 486-503 (2020)

مصطلحات موضوعية: innovation, ISO 13485, ISO 14001, ISO 22000, ISO 27001, ISO 50001, Business, HF5001-6182

وصف الملف: electronic resource

Relation: https://businessperspectives.org/images/pdf/applications/publishing/templates/article/assets/14522/PPM_2020_04_Mentel.pdf; https://doaj.org/toc/1727-7051; https://doaj.org/toc/1810-5467

URL الوصول: https://doaj.org/article/c35b498dc9844e649f7c334466e56c8c

المؤلفون: Yudan Whulanza, Sugeng Supriadi, Mochammad Chalid, Prasetyanugraheni Kreshanti, Anna Amalyah Agus, Paulus Napitupulu, Joni W. Supriyanto, Edi Rivai, Andri Purnomo

المصدر: International Journal of Technology, Vol 11, Iss 5, Pp 888-899 (2020)

مصطلحات موضوعية: covid-19 pandemic, iso 13485, national swab stick, quality assurance, 100% local content, Technology, Technology (General), T1-995

وصف الملف: electronic resource

Relation: https://ijtech.eng.ui.ac.id/article/view/4335; https://doaj.org/toc/2086-9614; https://doaj.org/toc/2087-2100

URL الوصول: https://doaj.org/article/ea7e77bc26bc45de9a612a84b12ee4cf

المؤلفون: Vincent McGrane, Olivia McDermott, Anna Trubetskaya, Angelo Rosa, Michael Sony

مصطلحات موضوعية: Engineering, continuous improvement, medical device, MedTech, lean six sigma, ISO 13485, 21CFR 820, validation

Relation: https://figshare.com/articles/journal_contribution/The_effect_of_medical_device_regulations_on_deploying_a_lean_six_sigma_project/22709572

الاتاحة: https://doi.org/10.34961/researchrepository-ul.22709572.v1
https://figshare.com/articles/journal_contribution/The_effect_of_medical_device_regulations_on_deploying_a_lean_six_sigma_project/22709572

المؤلفون: Moreno Parra, Paula Alejandra, Restrepo Benavidez, Byron, Sánchez Martín, Paola Alejandra

مصطلحات موضوعية: integrated management systems, NTC ISO 14001: 2015, NTC ISO 45001: 2018, NTC ISO 13485: 2016, integration methodology, gaps, sistemas integrados de gestión, NTC ISO 14001:2015, NTC ISO 45001:2018, NTC ISO 13485:2016, metodología de integración, brechas, sistemas de gestão integrada, metodologia de integração, lacunas

وصف الملف: application/pdf

Relation: https://revistas.usantotomas.edu.co/index.php/signos/article/view/6668/6444; SIGNOS - Investigación en sistemas de gestión; Vol. 13 Núm. 2 (2021): SIGNOS, investigación en sistemas de gestión; 134-170; SIGNOS-Investigación en Sistemas de Gestión; Vol. 13 No. 2 (2021): SIGNOS, investigación en sistemas de gestión; 134-170; SIGNOS-Investigación en Sistemas de Gestión; v. 13 n. 2 (2021): SIGNOS, investigación en sistemas de gestión; 134-170; https://revistas.usantotomas.edu.co/index.php/signos/article/view/6668; http://hdl.handle.net/11634/42182

الاتاحة: http://hdl.handle.net/11634/42182
https://revistas.usantotomas.edu.co/index.php/signos/article/view/6668
https://doi.org/10.15332/24631140.6668

المؤلفون: Rajan, R.¹, Kumar, P. Raj²

المصدر: Asian Journal of Research in Social Sciences and Humanities 7(8):311-324. 2017

المؤلفون: Piwowarczyk vel Dabrowski, Maciej, Sandkuhl, Kurt, 1963

المصدر: Human Centred Intelligent Systems Smart Innovation, Systems and Technologies. :205-215

مصطلحات موضوعية: Architecture complexity, Enterprise architecture, Management system, Medical device, Commerce, Computer architecture, Information management, Laws and legislation, Medical information systems, Quality management, Best practices, ISO 13485, Literature analysis, Management systems, Market launch, Medical device manufacturers, Medical Devices, Quality management systems, Manufacture

وصف الملف: print

URL الوصول: https://urn.kb.se/resolve?urn=urn:nbn:se:hj:diva-59485

المؤلفون: Koichiro MATSUMOTO, Yoko YOSHIDA, 吉田 容子, 松元 恒一郎

المصدر: 生体医工学 / Transactions of Japanese Society for Medical and Biological Engineering. 2020, 58(2-3):93

المؤلفون: Klingspor, Sophie, Svensson, Niclas

مصطلحات موضوعية: kvalitetsledningssystem, kravspecifikation, Medical Engineering, 2016 [ISO 13485], continuous improvement, risk management, ständig förbättring, kvalitetsledning, requirement specification, ISO, riskhantering, quality management system, 2020 [ISO 14971], Medicinteknik, quality management

وصف الملف: application/pdf

URL الوصول: https://explore.openaire.eu/search/publication?articleId=od_______361::35aa6e4bee41ac4b9a6c3db4d93096ca
http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-507046

المؤلفون: Cortes, Susana de Jesus Gomes

المساهمون: Martins, Ana Lúcia Henriques

مصطلحات موضوعية: Sistema de gestão, M11, I Health, education, and welfare, I18, M Business administration and business economics - Marketing - Accounting - Personnel economics, 2016 [ISO 13485], Certified companies, Lean, Management system, Empresas certificadas, Ciências Sociais::Economia e Gestão [Domínio/Área Científica]

وصف الملف: application/pdf

URL الوصول: https://explore.openaire.eu/search/publication?articleId=od______1199::cca3c4d2d510fc9aed5135fc3b5d11d2
https://hdl.handle.net/10071/27475

المؤلفون: Ejheden, Jonah, Tapper, Teodor

مصطلحات موضوعية: MDR, QMS, Implementation, Hospital, ISO 13485, Gap-analysis, Implementering, Sjukhus, Gap-analys, Engineering and Technology, Teknik och teknologier

وصف الملف: application/pdf

Relation: TRITA-ITM-EX ; 2022:211

الاتاحة: http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-318191

المؤلفون: Omar Hussein, Yacquub, Holmgård, Elsa

مصطلحات موضوعية: 2015 [ISO 9001], MDR, Other Medical Engineering, GAP, QMS, Annan medicinteknik, 2016 [SS-EN ISO 13485]

وصف الملف: application/pdf

URL الوصول: https://explore.openaire.eu/search/publication?articleId=od_______260::71760ebca968f0a3a795acb3e5fa9f15
http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-316115

المؤلفون: Ejheden, Jonah, Tapper, Teodor

مصطلحات موضوعية: Teknik och teknologier, Engineering and Technology, QMS, MDR, Implementering, Sjukhus, ISO 13485, Gap-analys, Implementation, Hospital, Gap-analysis

وصف الملف: application/pdf

URL الوصول: https://explore.openaire.eu/search/publication?articleId=od_______260::c6c6f021a797d814416a9661ff93b6f6
http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-318191

المؤلفون: Ejheden, Jonah, Tapper, Teodor

مصطلحات موضوعية: MDR, QMS, Implementation, Hospital, ISO 13485, Gap-analysis, Implementering, Sjukhus, Gap-analys, Engineering and Technology, Teknik och teknologier

وصف الملف: application/pdf

Relation: TRITA-ITM-EX; 2022:211

الاتاحة: http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-318191

المؤلفون: Ramos Ramos, Javier, Cañaveral Rodríguez, Alix Fernanda, Camacho Camacho, Hernando

مصطلحات موضوعية: Sistema de gestão, ISO 13485, quality, eficácia, efficacy, calidad, dispositivos médicos, Management system, eficacia, medical devices, Sistema de gestión, qualidade

وصف الملف: application/pdf

URL الوصول: https://explore.openaire.eu/search/publication?articleId=od______3896::8197c138ca393eb4b26d12b4212cff43
https://hdl.handle.net/11634/42179

المؤلفون: Alix Fernanda Cañaveral Rodríguez, Javier Ramos Ramos, Hernando Camacho Camacho

المصدر: SIGNOS-Investigación en sistemas de gestión; Vol. 13 Núm. 2 (2021): SIGNOS, investigación en sistemas de gestión; 48-78
SIGNOS-Investigación en Sistemas de Gestión; Vol. 13 No. 2 (2021): SIGNOS, investigación en sistemas de gestión; 48-78
SIGNOS-Investigación en Sistemas de Gestión; v. 13 n. 2 (2021): SIGNOS, investigación en sistemas de gestión; 48-78

مصطلحات موضوعية: Structure (mathematical logic), ISO 13485, Quality management, SIMPLE (military communications protocol), Computer science, efficacy, calidad, Competitive advantage, eficacia, medical devices, Sistema de gestão, Engineering management, Mixed approach, Quality management system, quality, eficácia, Customer satisfaction, dispositivos médicos, Management system, Sistema de gestión, qualidade

وصف الملف: application/pdf

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b7dedac5b45f8ab8ff30c6c118773c7e
https://hdl.handle.net/11634/36976

المؤلفون: Paola Alejandra Sánchez Martín, Byron Restrepo Benavidez, Paula Alejandra Moreno Parra

مصطلحات موضوعية: Structure (mathematical logic), International standards organization, Computer science, gaps, 2016 [NTC ISO 13485], sistemas de gestão integrada, Iso standards, 2015 [NTC ISO 14001], metodología de integración, Engineering management, Quality management system, sistemas integrados de gestión, metodologia de integração, integration methodology, lacunas, Management system, 2018 [NTC ISO 45001], Normative, integrated management systems, brechas

وصف الملف: application/pdf

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f18de0b251da2d55b10628ac2de2163c
https://hdl.handle.net/11634/42182

المؤلفون: Maury Couoh, Ilse María

المصدر: RiuNet. Repositorio Institucional de la Universitat Politécnica de Valéncia
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مصطلحات موضوعية: Quality management system, ISO 13485, Producción aditiva, Procesos, Máster Universitario en Ingeniería Biomédica-Màster Universitari en Enginyeria Biomèdica, Additive manufacturing, INGENIERIA MECANICA, Process approach, Productos sanitarios, Technical file, Sistema de gestión de calidad, Medical device

وصف الملف: application/pdf

URL الوصول: https://explore.openaire.eu/search/publication?articleId=dedup_wf_001::61ff51e0243d74bc6c005c4222e8b02e
http://hdl.handle.net/10251/175403

المؤلفون: Gebhart, Aleli Isabella Helena

مصطلحات موضوعية: ISO 13485, Norm, agile Entwicklung, virtuelle Teams, Kennzahlen, Kennzahl, Medizinprodukt, Medizinprodukte, Qualitätsmanagement, Scrum

وصف الملف: text/html

URL الوصول: https://explore.openaire.eu/search/publication?articleId=od_____10668::8f067a060eec0a544f220a7dbd50233a