The relevance of Quality Management Systems in the medical device industry
Descripción del Articulo
As technology has advanced, increasingly sophisticated medical devices have been manufactured, which has led to an increase in market supply. However, the proliferation of poor quality equipment endangers the health and even the lives of consumers. In view of this situation, the implementation of IS...
| Autor: | |
|---|---|
| Formato: | artículo |
| Fecha de Publicación: | 2023 |
| Institución: | Escuela de Posgrado Newman |
| Repositorio: | Revistas - Escuela de Posgrado Newman |
| Lenguaje: | español |
| OAI Identifier: | oai:ojs.pkp.sfu.ca:article/308 |
| Enlace del recurso: | https://journals.epnewman.edu.pe/index.php/IBJ/article/view/308 |
| Nivel de acceso: | acceso abierto |
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The relevance of Quality Management Systems in the medical device industryLa relevancia de los Sistemas de Gestión de la Calidad en el sector de dispositivos médicosChuco Aguilar, Victoria Judith As technology has advanced, increasingly sophisticated medical devices have been manufactured, which has led to an increase in market supply. However, the proliferation of poor quality equipment endangers the health and even the lives of consumers. In view of this situation, the implementation of ISO 13485 standards and Good Manufacturing Practices (GMP) will ensure quality in the manufacture of medical devices, which will have an impact on consumer confidence. For this reason, the objective of this article is to highlight the relevance of Quality Management Systems (QMS) in the medical device industry. Finally, conclusions to be considered in future research are presented.A medida que avanza la tecnología, se han ido fabricando dispositivos médicos cada vez más sofisticados, lo que ha provocado un aumento de la oferta en el mercado. Sin embargo, la proliferación de equipos de mala calidad pone en peligro la salud e, inclusive, la vida de los consumidores. Ante tal situación, la implementación de las normas ISO 13485 y las Buenas Prácticas de Manufactura permite asegurar la calidad en la fabricación de dispositivos médicos, lo cual repercutirá en la confianza del consumidor. Por ese motivo, el objetivo del presente artículo es destacar la relevancia de los Sistemas de Gestión de la Calidad en la industria de los dispositivos médicos. Finalmente, se plantean las conclusiones a ser consideradas en futuras investigaciones.Escuela de Posgrado Newman S.A.C.2023-07-31info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionPeer reviewed articleArtículo evaluado por paresapplication/pdftext/htmlhttps://journals.epnewman.edu.pe/index.php/IBJ/article/view/308Iberoamerican Business Journal; Vol. 7 No. 1 (2023): February - July; 98-114Iberoamerican Business Journal; Vol. 7 Núm. 1 (2023): Febrero - Julio; 98-1142521-581710.22451/5817.ibj2023.vol7.1reponame:Revistas - Escuela de Posgrado Newmaninstname:Escuela de Posgrado Newmaninstacron:NEWMANspahttps://journals.epnewman.edu.pe/index.php/IBJ/article/view/308/591https://journals.epnewman.edu.pe/index.php/IBJ/article/view/308/590Derechos de autor 2023 Victoria Judith Chuco Aguilarhttps://creativecommons.org/licenses/by-nc-sa/4.0info:eu-repo/semantics/openAccessoai:ojs.pkp.sfu.ca:article/3082024-09-17T11:47:53Z |
| dc.title.none.fl_str_mv |
The relevance of Quality Management Systems in the medical device industry La relevancia de los Sistemas de Gestión de la Calidad en el sector de dispositivos médicos |
| title |
The relevance of Quality Management Systems in the medical device industry |
| spellingShingle |
The relevance of Quality Management Systems in the medical device industry Chuco Aguilar, Victoria Judith |
| title_short |
The relevance of Quality Management Systems in the medical device industry |
| title_full |
The relevance of Quality Management Systems in the medical device industry |
| title_fullStr |
The relevance of Quality Management Systems in the medical device industry |
| title_full_unstemmed |
The relevance of Quality Management Systems in the medical device industry |
| title_sort |
The relevance of Quality Management Systems in the medical device industry |
| dc.creator.none.fl_str_mv |
Chuco Aguilar, Victoria Judith |
| author |
Chuco Aguilar, Victoria Judith |
| author_facet |
Chuco Aguilar, Victoria Judith |
| author_role |
author |
| description |
As technology has advanced, increasingly sophisticated medical devices have been manufactured, which has led to an increase in market supply. However, the proliferation of poor quality equipment endangers the health and even the lives of consumers. In view of this situation, the implementation of ISO 13485 standards and Good Manufacturing Practices (GMP) will ensure quality in the manufacture of medical devices, which will have an impact on consumer confidence. For this reason, the objective of this article is to highlight the relevance of Quality Management Systems (QMS) in the medical device industry. Finally, conclusions to be considered in future research are presented. |
| publishDate |
2023 |
| dc.date.none.fl_str_mv |
2023-07-31 |
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info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Peer reviewed article Artículo evaluado por pares |
| format |
article |
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publishedVersion |
| dc.identifier.none.fl_str_mv |
https://journals.epnewman.edu.pe/index.php/IBJ/article/view/308 |
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https://journals.epnewman.edu.pe/index.php/IBJ/article/view/308 |
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spa |
| language |
spa |
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https://journals.epnewman.edu.pe/index.php/IBJ/article/view/308/591 https://journals.epnewman.edu.pe/index.php/IBJ/article/view/308/590 |
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Derechos de autor 2023 Victoria Judith Chuco Aguilar https://creativecommons.org/licenses/by-nc-sa/4.0 info:eu-repo/semantics/openAccess |
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Derechos de autor 2023 Victoria Judith Chuco Aguilar https://creativecommons.org/licenses/by-nc-sa/4.0 |
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openAccess |
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application/pdf text/html |
| dc.publisher.none.fl_str_mv |
Escuela de Posgrado Newman S.A.C. |
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Escuela de Posgrado Newman S.A.C. |
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Iberoamerican Business Journal; Vol. 7 No. 1 (2023): February - July; 98-114 Iberoamerican Business Journal; Vol. 7 Núm. 1 (2023): Febrero - Julio; 98-114 2521-5817 10.22451/5817.ibj2023.vol7.1 reponame:Revistas - Escuela de Posgrado Newman instname:Escuela de Posgrado Newman instacron:NEWMAN |
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Escuela de Posgrado Newman |
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NEWMAN |
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Revistas - Escuela de Posgrado Newman |
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Nota importante:
La información contenida en este registro es de entera responsabilidad de la institución que gestiona el repositorio institucional donde esta contenido este documento o set de datos. El CONCYTEC no se hace responsable por los contenidos (publicaciones y/o datos) accesibles a través del Repositorio Nacional Digital de Ciencia, Tecnología e Innovación de Acceso Abierto (ALICIA).
La información contenida en este registro es de entera responsabilidad de la institución que gestiona el repositorio institucional donde esta contenido este documento o set de datos. El CONCYTEC no se hace responsable por los contenidos (publicaciones y/o datos) accesibles a través del Repositorio Nacional Digital de Ciencia, Tecnología e Innovación de Acceso Abierto (ALICIA).
