{"id":3437,"date":"2021-12-01T10:20:00","date_gmt":"2021-12-01T09:20:00","guid":{"rendered":"https:\/\/grupoloyal.net\/curso-medical-device-iso-13485-21-cfr-820\/"},"modified":"2021-12-01T10:20:00","modified_gmt":"2021-12-01T09:20:00","slug":"curso-medical-device-iso-13485-21-cfr-820","status":"publish","type":"post","link":"https:\/\/grupoloyal.net\/curso-medical-device-iso-13485-21-cfr-820\/","title":{"rendered":"Medical device – ISO 13485 + 21 CFR 820"},"content":{"rendered":"

[et_pb_section fb_built=\u00bb1″ fullwidth=\u00bbon\u00bb _builder_version=\u00bb4.4.0″][et_pb_fullwidth_image src=\u00bbhttps:\/\/grupoloyal.net\/wp-content\/uploads\/2022\/02\/curso-e1645533395126.jpg\u00bb _builder_version=\u00bb4.4.0″ hover_enabled=\u00bb0″ min_height=\u00bb223.3px\u00bb height=\u00bb530px\u00bb][\/et_pb_fullwidth_image][\/et_pb_section][et_pb_section fb_built=\u00bb1″ _builder_version=\u00bb4.4.0″ min_height=\u00bb106px\u00bb custom_padding=\u00bb12px||0px|||\u00bb background_color=\u00bb#eaeaea\u00bb hover_enabled=\u00bb0″][et_pb_row _builder_version=\u00bb4.4.0″][et_pb_column _builder_version=\u00bb4.4.0″ type=\u00bb4_4″][et_pb_text _builder_version=\u00bb4.4.0″ hover_enabled=\u00bb0″]<\/p>\n

Medical device – ISO 13485 + 21 CFR 820<\/h1>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1″ _builder_version=\u00bb4.4.0″ custom_padding=\u00bb52px|||||\u00bb][et_pb_row column_structure=\u00bb3_5,2_5″ _builder_version=\u00bb4.4.0″ hover_enabled=\u00bb0″][et_pb_column type=\u00bb3_5″ _builder_version=\u00bb4.4.0″ hover_enabled=\u00bb0″][et_pb_blurb title=\u00bbObjetivos\u00bb image=\u00bbhttp:\/\/itformacion.ivanosuna.com\/wp-content\/uploads\/2020\/09\/curso-objetivos.png\u00bb icon_placement=\u00bbleft\u00bb _builder_version=\u00bb4.4.0″ hover_enabled=\u00bb0″ header_font_size=\u00bb19px\u00bb]
\n Este curso proporciona una exposici\u00f3n en profundidad a los conceptos fundamentales y los principales problemas centrales para el cumplimiento normativo en el sector de dispositivos m\u00e9dicos.
\n El curso enfatiza el uso de los principios de las regulaciones del sistema de calidad de dispositivos m\u00e9dicos (QS) e ISO 13485 como herramientas para adoptar un enfoque de cumplimiento orientado al proceso y basado en riesgos, al tiempo que se logran los objetivos comerciales estrat\u00e9gicos en el din\u00e1mico entorno regulatorio actual.
\n Aprender\u00e1 sobre los procesos clave en la regulaci\u00f3n de dispositivos m\u00e9dicos del sistema de calidad (21 CFR 820) e ISO 13485, mientras aprende c\u00f3mo abordar los desaf\u00edos de incumplimiento desde un punto de vista pr\u00e1ctico.
\n El curso tambi\u00e9n analiza las tendencias actuales de la industria, las iniciativas de la FDA, las mejores pr\u00e1cticas para interactuar con las agencias reguladoras y una breve descripci\u00f3n general de los programas de la t\u00e9cnica de inspecci\u00f3n del sistema de calidad de la FDA (QSIT) y la auditor\u00eda \u00fanica de dispositivos m\u00e9dicos (MDSAP).<\/p>\n

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=\u00bb2_5″ _builder_version=\u00bb4.4.0″][et_pb_blurb image=\u00bbhttp:\/\/itformacion.ivanosuna.com\/wp-content\/uploads\/2020\/09\/curso-palabras-clave-300×300.png\u00bb icon_placement=\u00bbleft\u00bb _builder_version=\u00bb4.4.0″ hover_enabled=\u00bb0″]<\/p>\n

farma<\/strong><\/p>\n

[\/et_pb_blurb][et_pb_blurb image=\u00bbhttp:\/\/itformacion.ivanosuna.com\/wp-content\/uploads\/2020\/09\/curso-elearning-300×194.png\u00bb icon_placement=\u00bbleft\u00bb _builder_version=\u00bb4.4.0″ hover_enabled=\u00bb0″]<\/p>\n

Disponible en formato e-learning<\/strong><\/p>\n

[\/et_pb_blurb][et_pb_blurb image=\u00bbhttp:\/\/itformacion.ivanosuna.com\/wp-content\/uploads\/2020\/09\/curso-presencial.png\u00bb icon_placement=\u00bbleft\u00bb _builder_version=\u00bb4.4.0″ hover_enabled=\u00bb0″]<\/p>\n

Disponible en formato presencial<\/strong><\/p>\n

[\/et_pb_blurb][et_pb_blurb image=\u00bbhttp:\/\/itformacion.ivanosuna.com\/wp-content\/uploads\/2020\/09\/curso-remoto-300×300.png\u00bb icon_placement=\u00bbleft\u00bb _builder_version=\u00bb4.4.0″ hover_enabled=\u00bb0″]<\/p>\n

Disponible en formato a distancia<\/strong><\/p>\n

[\/et_pb_blurb][et_pb_blurb image=\u00bbhttp:\/\/itformacion.ivanosuna.com\/wp-content\/uploads\/2020\/09\/curso-remoto-300×300.png\u00bb icon_placement=\u00bbleft\u00bb _builder_version=\u00bb4.4.0″ hover_enabled=\u00bb0″]<\/p>\n

Acceso al campus<\/strong><\/a><\/p>\n

[\/et_pb_blurb][et_pb_blurb image=\u00bbhttp:\/\/itformacion.ivanosuna.com\/wp-content\/uploads\/2020\/09\/curso-subvencionado-300×300.png\u00bb icon_placement=\u00bbleft\u00bb _builder_version=\u00bb4.4.0″ hover_enabled=\u00bb0″]<\/p>\n

Subvenci\u00f3n disponible<\/strong>
\nA trav\u00e9s de Fundae, cumpliendo requisitos.<\/p>\n

[\/et_pb_blurb][et_pb_blurb image=\u00bbhttp:\/\/itformacion.ivanosuna.com\/wp-content\/uploads\/2020\/09\/curso-duracion-1-290×300.png\u00bb icon_placement=\u00bbleft\u00bb _builder_version=\u00bb4.4.0″ hover_enabled=\u00bb0″]<\/p>\n

Duraci\u00f3n<\/strong>
\n24<\/p>\n

[\/et_pb_blurb][et_pb_counters _builder_version=\u00bb4.4.0″][et_pb_counter percent=\u00bb50″ _builder_version=\u00bb4.4.0″ percent_text_color=\u00bb#e88b00″ background_enable_color_default=\u00bbon\u00bb parallax_default=\u00bboff\u00bb parallax_method_default=\u00bbon\u00bb bar_background_color_default=\u00bb#e88b00″ use_percentages=\u00bbon\u00bb allow_player_pause_default=\u00bboff\u00bb]Dificultad[\/et_pb_counter][et_pb_counter percent=\u00bb80″ _builder_version=\u00bb4.4.0″ percent_text_color=\u00bb#e88b00″ background_enable_color_default=\u00bbon\u00bb parallax_default=\u00bboff\u00bb parallax_method_default=\u00bbon\u00bb bar_background_color_default=\u00bb#e88b00″ use_percentages=\u00bbon\u00bb allow_player_pause_default=\u00bboff\u00bb]Nivel alcanzado[\/et_pb_counter][\/et_pb_counters][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1″ _builder_version=\u00bb4.4.0″ background_color=\u00bb#eeeeee\u00bb min_height=\u00bb194px\u00bb custom_padding=\u00bb17px||19px|||\u00bb][et_pb_row column_structure=\u00bb1_2,1_2″ _builder_version=\u00bb4.4.0″][et_pb_column type=\u00bb1_2″ _builder_version=\u00bb4.4.0″][et_pb_blurb title=\u00bbDirigido a\u00bb image=\u00bbhttp:\/\/itformacion.ivanosuna.com\/wp-content\/uploads\/2020\/09\/curso-dirigido-a-300×268.png\u00bb icon_placement=\u00bbleft\u00bb _builder_version=\u00bb4.4.0″ child_filter_saturate=\u00bb0%\u00bb child_filter_brightness=\u00bb200%\u00bb]<\/p>\n

\n
\n<\/div>\n<\/div>\n
\n
<\/div>\n<\/div>\n

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=\u00bb1_2″ _builder_version=\u00bb4.4.0″][et_pb_blurb title=\u00bbConocimientos requeridos\u00bb image=\u00bbhttp:\/\/itformacion.ivanosuna.com\/wp-content\/uploads\/2020\/09\/curso-skils.png\u00bb icon_placement=\u00bbleft\u00bb _builder_version=\u00bb4.4.0″ custom_margin=\u00bb||-120px|||\u00bb child_filter_saturate=\u00bb0%\u00bb child_filter_brightness=\u00bb200%\u00bb]<\/p>\n

\n
\n
\n<\/div>\n<\/div>\n
\n
<\/div>\n<\/div>\n

[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1″ _builder_version=\u00bb4.4.0″ custom_margin=\u00bb1px|||||\u00bb][et_pb_row _builder_version=\u00bb4.4.0″][et_pb_column type=\u00bb4_4″ _builder_version=\u00bb4.4.0″]
\n[et_pb_text content_tablet=\u00bb\u00bb]<\/p>\n

Temario<\/h2>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1″ _builder_version=\u00bb4.4.0″ background_color=\u00bb#032b35″][et_pb_row _builder_version=\u00bb4.4.0″][et_pb_column type=\u00bb4_4″ _builder_version=\u00bb4.4.0″][et_pb_contact_form captcha=\u00bboff\u00bb title=\u00bbSolicita informaci\u00f3n del curso\u00bb submit_button_text=\u00bbSolicitar informaci\u00f3n ahora\u00bb _builder_version=\u00bb4.4.0″ title_text_color=\u00bb#ffffff\u00bb title_font_size=\u00bb30px\u00bb][et_pb_contact_field field_id=\u00bbName\u00bb field_title=\u00bbNombre\u00bb _builder_version=\u00bb3.16″ button_text_size__hover_enabled=\u00bboff\u00bb button_one_text_size__hover_enabled=\u00bboff\u00bb button_two_text_size__hover_enabled=\u00bboff\u00bb button_text_color__hover_enabled=\u00bboff\u00bb button_one_text_color__hover_enabled=\u00bboff\u00bb button_two_text_color__hover_enabled=\u00bboff\u00bb button_border_width__hover_enabled=\u00bboff\u00bb button_one_border_width__hover_enabled=\u00bboff\u00bb button_two_border_width__hover_enabled=\u00bboff\u00bb button_border_color__hover_enabled=\u00bboff\u00bb button_one_border_color__hover_enabled=\u00bboff\u00bb button_two_border_color__hover_enabled=\u00bboff\u00bb button_border_radius__hover_enabled=\u00bboff\u00bb button_one_border_radius__hover_enabled=\u00bboff\u00bb button_two_border_radius__hover_enabled=\u00bboff\u00bb button_letter_spacing__hover_enabled=\u00bboff\u00bb button_one_letter_spacing__hover_enabled=\u00bboff\u00bb button_two_letter_spacing__hover_enabled=\u00bboff\u00bb button_bg_color__hover_enabled=\u00bboff\u00bb button_one_bg_color__hover_enabled=\u00bboff\u00bb button_two_bg_color__hover_enabled=\u00bboff\u00bb][\/et_pb_contact_field][et_pb_contact_field field_id=\u00bbEmail\u00bb field_title=\u00bbDirecci\u00f3n de correo electr\u00f3nico\u00bb field_type=\u00bbemail\u00bb _builder_version=\u00bb3.16″ button_text_size__hover_enabled=\u00bboff\u00bb button_one_text_size__hover_enabled=\u00bboff\u00bb button_two_text_size__hover_enabled=\u00bboff\u00bb button_text_color__hover_enabled=\u00bboff\u00bb button_one_text_color__hover_enabled=\u00bboff\u00bb button_two_text_color__hover_enabled=\u00bboff\u00bb button_border_width__hover_enabled=\u00bboff\u00bb button_one_border_width__hover_enabled=\u00bboff\u00bb button_two_border_width__hover_enabled=\u00bboff\u00bb button_border_color__hover_enabled=\u00bboff\u00bb button_one_border_color__hover_enabled=\u00bboff\u00bb button_two_border_color__hover_enabled=\u00bboff\u00bb button_border_radius__hover_enabled=\u00bboff\u00bb button_one_border_radius__hover_enabled=\u00bboff\u00bb button_two_border_radius__hover_enabled=\u00bboff\u00bb button_letter_spacing__hover_enabled=\u00bboff\u00bb button_one_letter_spacing__hover_enabled=\u00bboff\u00bb button_two_letter_spacing__hover_enabled=\u00bboff\u00bb button_bg_color__hover_enabled=\u00bboff\u00bb button_one_bg_color__hover_enabled=\u00bboff\u00bb button_two_bg_color__hover_enabled=\u00bboff\u00bb][\/et_pb_contact_field][et_pb_contact_field field_id=\u00bbEmpresa\u00bb field_title=\u00bbEmpresa\u00bb fullwidth_field=\u00bbon\u00bb _builder_version=\u00bb4.4.0″][\/et_pb_contact_field][et_pb_contact_field field_id=\u00bbMessage\u00bb field_title=\u00bbCu\u00e9ntanos un poco sobre tus necesidades\u00bb field_type=\u00bbtext\u00bb fullwidth_field=\u00bbon\u00bb _builder_version=\u00bb4.4.0″ form_field_text_color=\u00bb#555555″ button_text_size__hover_enabled=\u00bboff\u00bb button_one_text_size__hover_enabled=\u00bboff\u00bb button_two_text_size__hover_enabled=\u00bboff\u00bb button_text_color__hover_enabled=\u00bboff\u00bb button_one_text_color__hover_enabled=\u00bboff\u00bb button_two_text_color__hover_enabled=\u00bboff\u00bb button_border_width__hover_enabled=\u00bboff\u00bb button_one_border_width__hover_enabled=\u00bboff\u00bb button_two_border_width__hover_enabled=\u00bboff\u00bb button_border_color__hover_enabled=\u00bboff\u00bb button_one_border_color__hover_enabled=\u00bboff\u00bb button_two_border_color__hover_enabled=\u00bboff\u00bb button_border_radius__hover_enabled=\u00bboff\u00bb button_one_border_radius__hover_enabled=\u00bboff\u00bb button_two_border_radius__hover_enabled=\u00bboff\u00bb button_letter_spacing__hover_enabled=\u00bboff\u00bb button_one_letter_spacing__hover_enabled=\u00bboff\u00bb button_two_letter_spacing__hover_enabled=\u00bboff\u00bb button_bg_color__hover_enabled=\u00bboff\u00bb button_one_bg_color__hover_enabled=\u00bboff\u00bb button_two_bg_color__hover_enabled=\u00bboff\u00bb][\/et_pb_contact_field][\/et_pb_contact_form][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

24 horas<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"2880","footnotes":""},"categories":[9,11,64],"tags":[],"class_list":["post-3437","post","type-post","status-publish","format-standard","hentry","category-cursos","category-cursos-de-it","category-farma"],"acf":[],"_links":{"self":[{"href":"https:\/\/grupoloyal.net\/wp-json\/wp\/v2\/posts\/3437","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/grupoloyal.net\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/grupoloyal.net\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/grupoloyal.net\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/grupoloyal.net\/wp-json\/wp\/v2\/comments?post=3437"}],"version-history":[{"count":0,"href":"https:\/\/grupoloyal.net\/wp-json\/wp\/v2\/posts\/3437\/revisions"}],"wp:attachment":[{"href":"https:\/\/grupoloyal.net\/wp-json\/wp\/v2\/media?parent=3437"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/grupoloyal.net\/wp-json\/wp\/v2\/categories?post=3437"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/grupoloyal.net\/wp-json\/wp\/v2\/tags?post=3437"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}