{"id":15798,"date":"2019-06-12T09:29:35","date_gmt":"2019-06-12T07:29:35","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=15798"},"modified":"2023-01-26T11:32:04","modified_gmt":"2023-01-26T10:32:04","slug":"que-es-el-sistema-de-vigilancia-posterior-al-mercado","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2019\/06\/12\/que-es-el-sistema-de-vigilancia-posterior-al-mercado\/","title":{"rendered":"\u00bfQu\u00e9 es el \u201csistema de vigilancia posterior al mercado\u201d?"},"content":{"rendered":"\r\n<p>El <strong>sistema de vigilancia posterior al mercado<\/strong> (PMS) sirve para \u201crecopilar, registrar y analizar de forma activa y sistem\u00e1tica los datos pertinentes sobre la calidad, el rendimiento y la seguridad de un dispositivo durante su per\u00edodo de validez, a extraer las conclusiones necesarias y determinar, aplicar y supervisar las posibles acciones preventivas y correctoras\u201d (Ref. Art. 83 del MDR).<\/p>\r\n\r\n\r\n\r\n<p>La necesidad de este sistema surge inmediatamente despu\u00e9s de la comercializaci\u00f3n del dispositivo. El sistema PMS no s\u00f3lo sirve para cumplir los requisitos reglamentarios, sino tambi\u00e9n para mejorar la gesti\u00f3n de riesgos y mejorar la calidad de un dispositivo m\u00e9dico. El sistema PMS sirve para identificar adecuadamente los problemas en el dise\u00f1o y\/o el uso del dispositivo y para caracterizar con precisi\u00f3n el comportamiento de este dispositivo en condiciones normales de uso y los resultados cl\u00ednicos obtenidos.<\/p>\r\n\r\n\r\n\r\n<p>La vigilancia tambi\u00e9n forma parte del sistema PMS. Parte \u201cviva\u201d del sistema PMS y elementos fundamentales del SGC son tambi\u00e9n el follow-up cl\u00ednico posterior al mercado (PMCF, para los dispositivos m\u00e9dicos) y el follow-up del rendimiento posterior al mercado (PMPF, para los IVD). Estos procesos continuos, que forman parte de la evaluaci\u00f3n cl\u00ednica\/del rendimiento, se dirigen a llenar la brecha entre las evidencias recogidas durante la fase pre-market y los datos PMS recogidos sobre el dispositivo ya en uso.<\/p>\r\n\r\n\r\n\r\n<p class=\"has-text-color has-background\" style=\"background-color: #0099a8; color: #ffffff; text-align: center;\">Preguntas? Solicite m\u00e1s informaci\u00f3n a nuestros especialistas!<br \/><a href=\"https:\/\/www.thema-med.com\/es\/contactanos-2\/\" target=\"_blank\" rel=\"noreferrer noopener\">CONT\u00c1CTANOS<\/a><\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>El sistema de vigilancia posterior al mercado (PMS) sirve para \u201crecopilar, registrar y analizar de forma activa y sistem\u00e1tica los datos  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":23424,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1558,891],"tags":[],"class_list":["post-15798","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-impacto-mdr-en-los-certificados-ce-mdd-period-of-grace","category-faq-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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