The relevance of Quality Management Systems in the medical device industry

• Autor: Chuco Aguilar, Victoria Judith
• 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

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.