{"id":2599,"date":"2021-08-13T13:37:01","date_gmt":"2021-08-13T13:37:01","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/usfda-iacrc-webinar-series-on-medical-device-iso-13485-and-mdsap\/"},"modified":"2022-04-25T17:14:05","modified_gmt":"2022-04-25T17:14:05","slug":"usfda-iacrc-webinar-series-on-medical-device-iso-13485-and-mdsap","status":"publish","type":"regulator-sessions","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/usfda-iacrc-webinar-series-on-medical-device-iso-13485-and-mdsap\/?lang=es","title":{"rendered":"Serie de Seminarios Web sobre Dispositivos M\u00e9dicos: Modelos de Auditor\u00eda ISO 13485 y MDSAP"},"content":{"rendered":"\n

En Junio, el Proyecto de Convergencia Regulatoria de Dispositivos M\u00e9dicos<\/a> co-liderado por USAID, ANSI, y AdvaMed a trav\u00e9s de la Coalici\u00f3n Interamericana para la Convergencia Regulatoria en el Sector de Tecnolog\u00eda M\u00e9dica<\/a>, en colaboraci\u00f3n con la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (USFDA) han organizado una serie de sesiones web sobre la utilizaci\u00f3n de los resultados de las auditor\u00edas ISO 13485 y el Programa de Auditor\u00eda \u00danica (MDSAP) con prop\u00f3sitos regulatorios, en los que ANVISA y ANMAT, adem\u00e1s de la USFDA comparten sus experiencias.<\/p>\n\n\n\n

Presentaciones de cada sesi\u00f3n disponibles en Ingl\u00e9s, Portugu\u00e9s y Espa\u00f1ol:<\/p>\n\n\n\n

Parte I, 2 Junio, 2021<\/strong><\/h3>\n\n\n\n

Objective:<\/strong> Explicar la forma en que se llevan a cabo las auditor\u00edas de dispositivos M\u00e9dicos utilizando el modelo de \u201cMDSAP\u201d, que se basa en ISO 13485 y c\u00f3mo se pueden alinear las agencias respecto de ISO 13485.<\/p>\n\n\n\n

Agenda:<\/p>\n\n\n\n

\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n\n\n\n
Portugu\u00e9s<\/a><\/div>\n<\/div>\n\n\n\n

Grabaci\u00f3n de la Sesi\u00f3n Parte I:<\/p>\n\n\n\n

\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n\n\n\n
Portugu\u00e9s<\/a><\/div>\n<\/div>\n\n\n\n

Presentaci\u00f3n Modelo de Auditor\u00eda MDSAP:<\/p>\n\n\n\n

\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n\n\n\n
Portugu\u00e9s<\/a><\/div>\n<\/div>\n\n\n\n

Presentaci\u00f3n Programa de Evaluaci\u00f3n de Organizaciones Auditoras:<\/p>\n\n\n\n

\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n<\/div>\n\n\n\n

Presentaci\u00f3n \u2013 ANVISA (Good Manufacturing Practices in Brazil: Resolution RDC 16\/2013, similarities and differences compared to ISO 13485:2016)<\/p>\n\n\n\n

\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n\n\n\n
Portugu\u00e9s<\/a><\/div>\n<\/div>\n\n\n\n

Presentaci\u00f3n Transici\u00f3n de la USFDA de CFR820 a ISO 13485:<\/p>\n\n\n\n

\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n\n\n\n
Portugu\u00e9s<\/a><\/div>\n<\/div>\n\n\n\n

Parte II, 10 Junio, 2021<\/strong><\/h3>\n\n\n\n

Objective:<\/strong> Presentar c\u00f3mo se lleva a cabo una auditoria \u201cMDSAP\u201d y un caso de estudio para explicar el modelo de auditor\u00eda basado en ISO 13485.<\/p>\n\n\n\n

Agenda:<\/p>\n\n\n\n

\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n<\/div>\n\n\n\n

Grabaci\u00f3n de la Sesi\u00f3n Parte II:<\/p>\n\n\n\n

\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n\n\n\n
Portugu\u00e9s<\/a><\/div>\n<\/div>\n\n\n\n

Presentaci\u00f3n sobre la Experiencia empleando el modelo de Auditor\u00eda MDSAP:<\/p>\n\n\n\n

\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n\n\n\n
Portugu\u00e9s<\/a><\/div>\n<\/div>\n\n\n\n

Caso de Estudio: Diferentes aproximaciones de las autoridades regulatorias participantes vis a vis una auditoria de \u201cMDSAP\u201d para identificar similitudes y \u00e1reas de oportunidad para lograr la alineaci\u00f3n de criterios:<\/p>\n\n\n\n

\n
Certification Agenda (Ingl\u00e9s)<\/a><\/div>\n\n\n\n
Informe de auditoria (Ingl\u00e9s)<\/a><\/div>\n\n\n\n
Informe de auditoria (Espa\u00f1ol) [Traducci\u00f3n parcial]<\/a><\/div>\n\n\n\n
Informe de auditoria (Portugu\u00e9s) [Traducci\u00f3n parcial]<\/a><\/div>\n<\/div>\n\n\n\n

Parte III, 17 Junio, 2021<\/strong><\/h3>\n\n\n\n

Objective:<\/strong> Explicar el modelo de auditoria \u201cMDSAP\u201d, presentar las oportunidades para apalancar los resultados de la auditoria \u201cMDSAP\u201d y compartir la experiencia de un Miembro Afiliado, en el proceso de obtener este estatus y los beneficios que ha obtenido.<\/p>\n\n\n\n

Agenda:<\/p>\n\n\n\n

\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n<\/div>\n\n\n\n

Grabaci\u00f3n de la Sesi\u00f3n Part III:<\/p>\n\n\n\n

\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n\n\n\n
Portugu\u00e9s<\/a><\/div>\n<\/div>\n\n\n\n

Presentaciones:<\/h4>\n\n\n\n

C\u00f3mo usa Brasil los documentos de MDSAP:<\/p>\n\n\n\n

\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n\n\n\n
Portugu\u00e9s<\/a><\/div>\n<\/div>\n\n\n\n

Uso del MDSAP por la FDA:<\/p>\n\n\n\n

\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n\n\n\n
Portugu\u00e9s<\/a><\/div>\n<\/div>\n\n\n\n

Experiencia de ANMAT como Miembro Afiliado de MDSAP:<\/p>\n\n\n\n

\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n\n\n\n
Portugu\u00e9s<\/a><\/div>\n<\/div>\n\n\n\n

MDSAP programa de miembros afiliados:<\/p>\n\n\n\n

\n
Ingl\u00e9s<\/a><\/div>\n\n\n\n
Espa\u00f1ol<\/a><\/div>\n\n\n\n
Portugu\u00e9s<\/a><\/div>\n<\/div>\n","protected":false},"parent":0,"template":"","event_category":[],"class_list":["post-2599","regulator-sessions","type-regulator-sessions","status-publish","hentry","description-off"],"acf":[],"yoast_head":"\nSerie de Seminarios Web sobre Dispositivos M\u00e9dicos: Modelos de Auditor\u00eda ISO 13485 y MDSAP - Regulatory Convergence<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/usfda-iacrc-webinar-series-on-medical-device-iso-13485-and-mdsap\/?lang=es\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Serie de Seminarios Web sobre Dispositivos M\u00e9dicos: Modelos de Auditor\u00eda ISO 13485 y MDSAP - Regulatory Convergence\" \/>\n<meta property=\"og:description\" content=\"En Junio, el Proyecto de Convergencia Regulatoria de Dispositivos M\u00e9dicos co-liderado por USAID, ANSI, y AdvaMed a trav\u00e9s de la Coalici\u00f3n Interamericana para la Convergencia Regulatoria en el Sector de Tecnolog\u00eda M\u00e9dica, en colaboraci\u00f3n con la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (USFDA) han organizado una serie de sesiones web sobre la utilizaci\u00f3n de los…\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/training-and-capacity-building-resources\/regulator-sessions\/usfda-iacrc-webinar-series-on-medical-device-iso-13485-and-mdsap\/?lang=es\" \/>\n<meta property=\"og:site_name\" content=\"Regulatory Convergence\" \/>\n<meta property=\"article:modified_time\" content=\"2022-04-25T17:14:05+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/training-and-capacity-building-resources\\\/regulator-sessions\\\/usfda-iacrc-webinar-series-on-medical-device-iso-13485-and-mdsap\\\/?lang=es\",\"url\":\"https:\\\/\\\/www.interamericancoalition-medtech.org\\\/regulatory-convergence\\\/training-and-capacity-building-resources\\\/regulator-sessions\\\/usfda-iacrc-webinar-series-on-medical-device-iso-13485-and-mdsap\\\/?lang=es\",\"name\":\"Serie de Seminarios Web sobre Dispositivos M\u00e9dicos: Modelos de Auditor\u00eda ISO 13485 y MDSAP - 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