{"id":36603,"date":"2023-09-08T08:21:39","date_gmt":"2023-09-08T15:21:39","guid":{"rendered":"https:\/\/www.arenasolutions.com\/cumplimiento-normativo-sobre-dispositivos-medicos\/"},"modified":"2025-10-17T09:28:28","modified_gmt":"2025-10-17T16:28:28","slug":"cumplimiento-normativo-sobre-dispositivos-medicos","status":"publish","type":"page","link":"https:\/\/www.arenasolutions.com\/es\/solutions\/compliance-management\/medical-devices\/","title":{"rendered":"Cumplimiento normativo sobre dispositivos m\u00e9dicos"},"content":{"rendered":"<p>[et_pb_section fb_built=\u00bb1&#8243; admin_label=\u00bbhero section\u00bb module_class=\u00bbhero-section\u00bb _builder_version=\u00bb4.17.4&#8243; background_image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Hero-solutions-medical-devices-1.jpg\u00bb custom_padding=\u00bb30px||30px||true|false\u00bb background_last_edited=\u00bbon|tablet\u00bb background_image_tablet=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/dark-purple-background.jpg\u00bb background_enable_image_tablet=\u00bbon\u00bb collapsed=\u00bbon\u00bb global_colors_info=\u00bb{}\u00bb title_text_tablet=\u00bbdark-purple-background\u00bb alt_tablet=\u00bbDark Purple Background\u00bb][et_pb_row column_structure=\u00bb1_2,1_2&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_2&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.16&#8243; header_text_color=\u00bb#FFFFFF\u00bb header_3_text_color=\u00bb#FFFFFF\u00bb header_4_font=\u00bbOpen Sans|600|||||||\u00bb header_4_text_color=\u00bb#FFFFFF\u00bb custom_margin=\u00bb||0px||false|false\u00bb custom_padding=\u00bb||0px|||\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h1>Cumplimiento de la <br class=\"hidden-on-mobile\" \/>normativa sobre <br class=\"hidden-on-mobile\" \/>dispositivos m\u00e9dicos<\/h1>\n<p>[\/et_pb_text][et_pb_text _builder_version=\u00bb4.16&#8243; header_4_text_color=\u00bb#FFFFFF\u00bb custom_padding=\u00bb0px|||||\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h4>Simplificaci\u00f3n del cumplimiento normativo de FDA, EU MDR e ISO<\/h4>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_2&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb15px||55px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb||18px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.18.0&#8243; header_2_text_align=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h2 style=\"text-align: center;\" class=\"dark-green\"><span>AGILIZACI\u00d3N DE LA PREPARACI\u00d3N PARA LAS NORMATIVAS Y REQUISITOS<\/span><\/h2>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00bb1_2,1_2&#8243; make_equal=\u00bbon\u00bb _builder_version=\u00bb4.16&#8243; custom_margin=\u00bb||50px||false|false\u00bb custom_padding=\u00bb||||false|false\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_2&#8243; _builder_version=\u00bb4.16&#8243; custom_css_main_element=\u00bbdisplay: grid;\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_image src=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Med-Dev-Expedite-Readiness.jpg\u00bb alt=\u00bbCumplimiento de la normativa de seguridad sobre dispositivos m\u00e9dicos\u00bb title_text=\u00bbMed-Dev-Expedite-Readiness\u00bb align=\u00bbcenter\u00bb _builder_version=\u00bb4.18.0&#8243; max_width=\u00bb575px\u00bb global_colors_info=\u00bb{}\u00bb][\/et_pb_image][\/et_pb_column][et_pb_column type=\u00bb1_2&#8243; _builder_version=\u00bb4.16&#8243; custom_css_main_element=\u00bbdisplay: grid;||align-items: center;\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><span>Para garantizar la seguridad de los pacientes, los fabricantes de dispositivos m\u00e9dicos deben establecer y mantener sistemas de calidad que logren el cumplimiento de la normativa que especifican la <a href=\"https:\/\/www.arenasolutions.com\/resources\/glossary\/fda-compliance\/\">FDA<\/a>, la <a href=\"https:\/\/www.arenasolutions.com\/resources\/glossary\/european-union-medical-device-regulation\/\">EU MDR<\/a>, la <a href=\"https:\/\/www.arenasolutions.com\/resources\/glossary\/iso\/\">ISO<\/a> y otros organismos reguladores. Cumplir normativas como la 21 CFR, Parte 820 de la FDA y la ISO 13485 es clave para el \u00e9xito de su comercializaci\u00f3n.<\/span><\/p>\n<p><span>El software QMS basado en la nube de Arena le ayuda a conseguir y mantener s\u00f3lidos <a href=\"https:\/\/www.arenasolutions.com\/es\/solutions\/design-controls\/\">controles de dise\u00f1o<\/a>. Esto simplifica la administraci\u00f3n de los procedimientos normalizados de trabajo (SOP), los archivos de historial de dispositivos (DHF), los registros de dispositivos maestros (DMR), los registros de formaci\u00f3n y todo el registro de productos, al vincular toda la informaci\u00f3n sobre calidad y productos a lo largo del desarrollo y la introducci\u00f3n de nuevos productos.<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; admin_label=\u00bbEXPLORE ARENA&#8217;S COMPREHENSIVE PLM PLATFORM\u00bb _builder_version=\u00bb4.16&#8243; background_image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/gray-bg-1.jpg\u00bb custom_padding=\u00bb26px||54px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb||0px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.18.0&#8243; text_text_color=\u00bb#FFFFFF\u00bb header_2_text_align=\u00bbcenter\u00bb header_2_text_color=\u00bb#000000&#8243; text_orientation=\u00bbcenter\u00bb custom_margin=\u00bb||0px|||\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h2 class=\"dark-green\" style=\"text-align: center;\"><span style=\"color: #00890b;\">QMS EN LA NUBE SIMPLIFICA EL CUMPLIMIENTO DE LA NORMATIVA<\/span><\/h2>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb16px||32px|||\u00bb custom_css_main_element=\u00bbmax-width: 1100px !important;\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.16&#8243; text_orientation=\u00bbcenter\u00bb module_alignment=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><span>Introducir un <a href=\"https:\/\/www.arenasolutions.com\/es\/medical-device\/\">dispositivo m\u00e9dico seguro, conforme a la normativa e innovador en el mercado<\/a> no es tarea f\u00e1cil. De hecho, requiere una organizaci\u00f3n entre sus equipos de calidad, ingenier\u00eda y operaciones, junto con sus socios de la cadena de suministro.&nbsp;<\/span><span>El software <a href=\"https:\/\/www.arenasolutions.com\/es\/platform\/qms\/\">Arena Quality Management System (QMS)<\/a> proporciona un \u00fanico sistema fiable para desarrollar e introducir dispositivos, al tiempo que elimina los riesgos de cumplimiento.<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00bb1_3,1_3,1_3&#8243; use_custom_gutter=\u00bbon\u00bb gutter_width=\u00bb1&#8243; make_equal=\u00bbon\u00bb module_class=\u00bbfive-column-boxes white-boxes-row\u00bb _builder_version=\u00bb4.16&#8243; max_width=\u00bb1200px\u00bb module_alignment=\u00bbcenter\u00bb custom_padding=\u00bb6px||6px||true|false\u00bb custom_css_main_element=\u00bbmax-width: 990px !important;\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_3&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_blurb image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-QUALITY-TEAMS.svg\u00bb alt=\u00bbIcono de garant\u00eda de calidad\u00bb _builder_version=\u00bb4.27.4&#8243; header_font=\u00bb|700|||||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#00890b\u00bb background_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb height=\u00bb100%\u00bb custom_padding=\u00bb30px|20px|30px|20px|true|true\u00bb hover_enabled=\u00bb0&#8243; global_colors_info=\u00bb{}\u00bb title_text=\u00bbIcon-QUALITY TEAMS\u00bb sticky_enabled=\u00bb0&#8243;]<\/p>\n<h4><span style=\"color: #00890b;\">LOS EQUIPOS DE<\/span><br \/><span style=\"color: #00890b;\"> GARANT\u00cdA DE CALIDAD<\/span><\/h4>\n<p>siguen <a href=\"https:\/\/www.arenasolutions.com\/es\/solutions\/quality-management\/\">procesos cerrados de calidad<\/a> para mejorar la trazabilidad<\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=\u00bb1_3&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_blurb image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-Change-Analysts.svg\u00bb alt=\u00bbIcon-Change-Analysts\u00bb _builder_version=\u00bb4.27.4&#8243; header_font=\u00bb|700|||||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#00890b\u00bb background_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb height=\u00bb100%\u00bb custom_padding=\u00bb30px|20px|30px|20px|true|true\u00bb hover_enabled=\u00bb0&#8243; global_colors_info=\u00bb{}\u00bb sticky_enabled=\u00bb0&#8243; title_text=\u00bbIcon-Change-Analysts\u00bb]<\/p>\n<h4><span style=\"color: #00890b;\">LOS EQUIPOS DE<\/span><br \/><span style=\"color: #00890b;\">ASUNTOS NORMATIVOS<\/span><\/h4>\n<p>establecen s\u00f3lidos controles de dise\u00f1o y garantizan el cumplimiento de la normativa<\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=\u00bb1_3&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_blurb image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-MGMT-Teams.svg\u00bb alt=\u00bbIcon-MGMT-Teams\u00bb _builder_version=\u00bb4.27.4&#8243; header_font=\u00bb|700|||||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#00890b\u00bb background_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb height=\u00bb100%\u00bb custom_padding=\u00bb30px|20px|30px|20px|true|true\u00bb hover_enabled=\u00bb0&#8243; global_colors_info=\u00bb{}\u00bb title_text=\u00bbIcon-MGMT-Teams\u00bb sticky_enabled=\u00bb0&#8243;]<\/p>\n<h4><span style=\"color: #00890b;\">LOS EQUIPOS DE<\/span><br \/><span style=\"color: #00890b;\"> ADMINISTRACI\u00d3N<\/span><\/h4>\n<p>mejoran el cumplimiento de los <a href=\"https:\/\/www.arenasolutions.com\/es\/solutions\/training-management\/\">registros de formaci\u00f3n,<\/a> los SOP y mucho m\u00e1s<\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00bb1_3,1_3,1_3&#8243; use_custom_gutter=\u00bbon\u00bb gutter_width=\u00bb1&#8243; make_equal=\u00bbon\u00bb module_class=\u00bbfive-column-boxes white-boxes-row\u00bb _builder_version=\u00bb4.16&#8243; max_width=\u00bb1200px\u00bb module_alignment=\u00bbcenter\u00bb custom_padding=\u00bb6px||6px||true|false\u00bb custom_css_main_element=\u00bbmax-width: 990px !important;\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_3&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_blurb image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-ENGINEERING-TEAMS.svg\u00bb alt=\u00bbIcono de equipos de ingenier\u00eda\u00bb _builder_version=\u00bb4.27.4&#8243; header_font=\u00bb|700|||||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#00890b\u00bb background_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb height=\u00bb100%\u00bb custom_padding=\u00bb30px|20px|30px|20px|true|true\u00bb hover_enabled=\u00bb0&#8243; global_colors_info=\u00bb{}\u00bb title_text=\u00bbIcon-ENGINEERING TEAMS\u00bb sticky_enabled=\u00bb0&#8243;]<\/p>\n<h4><span style=\"color: #00890b;\">LOS EQUIPOS<br \/>DE INGENIER\u00cdA<\/span><\/h4>\n<p><span>obtienen visibilidad para seguir mejorando los dise\u00f1os conformes a la normativa&nbsp;<\/span><\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=\u00bb1_3&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_blurb image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-Doc-Mgmt.svg\u00bb alt=\u00bbIcono de control de documentos\u00bb _builder_version=\u00bb4.27.4&#8243; header_font=\u00bb|700|||||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#00890b\u00bb background_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb height=\u00bb100%\u00bb custom_padding=\u00bb30px|20px|30px|20px|true|true\u00bb hover_enabled=\u00bb0&#8243; global_colors_info=\u00bb{}\u00bb title_text=\u00bbIcon-Document Management\u00bb sticky_enabled=\u00bb0&#8243;]<\/p>\n<h4><span style=\"color: #00890b;\">EL EQUIPO DE CONTROL<\/span><br \/><span style=\"color: #00890b;\"> DE DOCUMENTOS<\/span><\/h4>\n<p>puede preparar y superar favorablemente <a href=\"https:\/\/www.arenasolutions.com\/resources\/articles\/fda-audit-tips\/\">auditor\u00edas de la FDA<\/a>, ISO, EU MDR o internas<\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][et_pb_column type=\u00bb1_3&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_blurb image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icons-EXECUTIVE-MANAGEMENT.svg\u00bb alt=\u00bbIcono de ejecutivo\u00bb _builder_version=\u00bb4.27.4&#8243; header_font=\u00bb|700|||||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#00890b\u00bb background_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb height=\u00bb100%\u00bb custom_padding=\u00bb30px|20px|30px|20px|true|true\u00bb hover_enabled=\u00bb0&#8243; global_colors_info=\u00bb{}\u00bb title_text=\u00bbIcons-EXECUTIVE MANAGEMENT\u00bb sticky_enabled=\u00bb0&#8243;]<\/p>\n<h4><span style=\"color: #00890b;\">LOS EQUIPOS DE ADMINISTRACI\u00d3N EJECUTIVA<\/span><\/h4>\n<p>pueden tomar mejores decisiones para acelerar la comercializaci\u00f3n<\/p>\n<p>[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb||60px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb||15px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text admin_label=\u00bbH2&#8243; _builder_version=\u00bb4.18.0&#8243; header_2_text_align=\u00bbcenter\u00bb custom_margin=\u00bb||17px|||\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h2 style=\"text-align: center;\" class=\"dark-green\">PROCESOS DE CALIDAD CONECTADOS<\/h2>\n<p>[\/et_pb_text][et_pb_text admin_label=\u00bbparagraph\u00bb _builder_version=\u00bb4.16&#8243; text_orientation=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><span>En un entorno regulado, la clave para introducir nuevos productos y mantener al mismo tiempo el cumplimiento normativo es conectar sus registros de productos y de calidad. El software QMS en la nube de Arena ofrece un enfoque enfocado en el producto que vincula los registros de calidad, formaci\u00f3n, proveedores y auditor\u00edas a toda la lista de materiales (LDM).<br \/><\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00bb1_3,1_3,1_3&#8243; use_custom_gutter=\u00bbon\u00bb gutter_width=\u00bb2&#8243; make_equal=\u00bbon\u00bb _builder_version=\u00bb4.18.0&#8243; width=\u00bb90%\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_3&#8243; module_class=\u00bbhover-copy-column red\u00bb _builder_version=\u00bb4.18.0&#8243; background_enable_color=\u00bboff\u00bb background_image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/quality-process.jpg\u00bb custom_padding=\u00bb||||true|true\u00bb background_last_edited=\u00bbon|desktop\u00bb global_colors_info=\u00bb{}\u00bb background__hover_enabled=\u00bbon|hover\u00bb background_color__hover=\u00bb#dc5000&#8243; background_enable_color__hover=\u00bbon\u00bb][et_pb_text admin_label=\u00bbPre-hover copy\u00bb module_class=\u00bbpre-hover-copy red\u00bb _builder_version=\u00bb4.19.0&#8243; header_2_text_align=\u00bbcenter\u00bb header_2_text_color=\u00bb#FFFFFF\u00bb header_4_text_align=\u00bbcenter\u00bb header_4_text_color=\u00bb#FFFFFF\u00bb width=\u00bb100%\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h4>OPTIMIZA <br \/>LOS PROCESOS CERRADOS<br \/>DE CALIDAD<\/h4>\n<p>[\/et_pb_text][et_pb_text admin_label=\u00bbHover copy\u00bb module_class=\u00bbhover-copy red\u00bb _builder_version=\u00bb4.18.0&#8243; text_text_color=\u00bb#FFFFFF\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<ul>\n<li><span>Facilita el acceso y la trazabilidad a todos los equipos para racionalizar la investigaci\u00f3n de los problemas y acelerar su resoluci\u00f3n<\/span><\/li>\n<li><span>Vincula los procesos de calidad y de medidas correctoras y preventivas (CAPA) al registro de productos para identificar, analizar y resolver los problemas r\u00e1pidamente<\/span><\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_3&#8243; module_class=\u00bbhover-copy-column orange\u00bb _builder_version=\u00bb4.18.0&#8243; background_enable_color=\u00bboff\u00bb background_image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/issue-resolution.jpg\u00bb global_colors_info=\u00bb{}\u00bb background__hover_enabled=\u00bbon|hover\u00bb background_color__hover=\u00bb#f99238&#8243; background_enable_color__hover=\u00bbon\u00bb][et_pb_text admin_label=\u00bbPre-hover copy\u00bb module_class=\u00bbpre-hover-copy orange\u00bb _builder_version=\u00bb4.19.0&#8243; header_2_text_align=\u00bbcenter\u00bb header_2_text_color=\u00bb#FFFFFF\u00bb header_4_text_align=\u00bbcenter\u00bb header_4_text_color=\u00bb#FFFFFF\u00bb width=\u00bb100%\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h4>REDUCE LOS RIESGOS DE <br \/>AUDITOR\u00cdA INTERNA <br \/>Y EXTERNA<\/h4>\n<p>[\/et_pb_text][et_pb_text admin_label=\u00bbHover copy\u00bb module_class=\u00bbhover-copy orange\u00bb _builder_version=\u00bb4.18.0&#8243; text_text_color=\u00bb#FFFFFF\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<ul>\n<li><span>Enlaza e indexa todo el registro de productos, incluidos el DMR y el DHF, para facilitar la b\u00fasqueda<\/span><\/li>\n<li><span>Reduce el riesgo de infracciones, incluidas las cartas de advertencia y las observaciones del formulario 483<\/span><\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_3&#8243; module_class=\u00bbhover-copy-column blue\u00bb _builder_version=\u00bb4.18.0&#8243; background_enable_color=\u00bboff\u00bb background_image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/single-system-of-truth.jpg\u00bb background_last_edited=\u00bbon|desktop\u00bb global_colors_info=\u00bb{}\u00bb background__hover_enabled=\u00bbon|desktop\u00bb background_color__hover=\u00bb#7b7bc1&#8243; background_enable_color__hover=\u00bbon\u00bb][et_pb_text admin_label=\u00bbPre-hover copy\u00bb module_class=\u00bbpre-hover-copy blue\u00bb _builder_version=\u00bb4.19.0&#8243; header_2_text_align=\u00bbcenter\u00bb header_2_text_color=\u00bb#FFFFFF\u00bb header_4_text_align=\u00bbcenter\u00bb header_4_text_color=\u00bb#FFFFFF\u00bb width=\u00bb100%\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h4>SIMPLIFICA LA <br \/>VALIDACI\u00d3N DEL <br \/>SISTEMA DE SOFTWARE<\/h4>\n<p>[\/et_pb_text][et_pb_text admin_label=\u00bbHover copy\u00bb module_class=\u00bbhover-copy blue\u00bb _builder_version=\u00bb4.18.0&#8243; text_text_color=\u00bb#FFFFFF\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<ul>\n<li><span>Documenta los resultados de las pruebas de validaci\u00f3n de cada actualizaci\u00f3n del producto a todos los suscriptores<\/span><\/li>\n<li><span>Reduce el tiempo y los costes asociados al desarrollo y la ejecuci\u00f3n de los casos de prueba<\/span><\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row module_class=\u00bblocale-hide-cn\u00bb _builder_version=\u00bb4.20.0&#8243; custom_padding=\u00bb29px||21px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.16&#8243; text_orientation=\u00bbcenter\u00bb custom_margin=\u00bb||5px||false|false\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><span>Descubra c\u00f3mo los siete principios de la administraci\u00f3n de la calidad enfocada en el producto simplifican el cumplimiento de la normativa.<\/span><\/p>\n<p>[\/et_pb_text][et_pb_button button_url=\u00bbhttps:\/\/www.arenasolutions.com\/white-papers\/7-principles-qms\/\u00bb button_text=\u00bbM\u00c1S INFORMACI\u00d3N\u00bb button_alignment=\u00bbcenter\u00bb _builder_version=\u00bb4.17.4&#8243; global_colors_info=\u00bb{}\u00bb][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; admin_label=\u00bbQuality Talk Video-Sanjay Banerjee\u00bb _builder_version=\u00bb4.19.0&#8243; background_image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/dark-purple-background.jpg\u00bb custom_padding=\u00bb30px||30px||true|\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row column_structure=\u00bb1_3,2_3&#8243; use_custom_gutter=\u00bbon\u00bb gutter_width=\u00bb1&#8243; make_equal=\u00bbon\u00bb _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb0px||0px||true|false\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_3&#8243; _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb|40px|||false|false\u00bb custom_padding_tablet=\u00bb|0px|||false|false\u00bb custom_padding_phone=\u00bb\u00bb custom_padding_last_edited=\u00bbon|tablet\u00bb custom_css_main_element=\u00bbdisplay: grid;||align-content: center;\u00bb border_color_right=\u00bb#FFFFFF\u00bb border_width_right_tablet=\u00bb0px\u00bb border_width_right_phone=\u00bb\u00bb border_width_right_last_edited=\u00bbon|tablet\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.18.0&#8243; header_2_text_align=\u00bbright\u00bb header_2_text_color=\u00bb#FFFFFF\u00bb header_2_font_size=\u00bb36px\u00bb text_orientation=\u00bbcenter\u00bb custom_padding=\u00bb||||false|true\u00bb link_option_url=\u00bb\/wp-content\/uploads\/Customer-Success-Sanjay-Banerjee-v01.mp4&#8243; header_2_text_align_tablet=\u00bbcenter\u00bb header_2_text_align_phone=\u00bb\u00bb header_2_text_align_last_edited=\u00bbon|tablet\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><a class=\"video-popup-button\" href=\"\/wp-content\/uploads\/Customer-Success-Sanjay-Banerjee-v01.mp4\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-16760 size-medium\" src=\"https:\/\/www.arenasolutions.com\/wp-content\/uploads\/Sanjay-Video-Thumbnail-ES.jpg\" alt=\"\" width=\"300\" height=\"169\"\/><\/a><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb2_3&#8243; _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb30px||30px|40px|true|false\u00bb custom_padding_tablet=\u00bb|||0px|false|false\u00bb custom_padding_phone=\u00bb\u00bb custom_padding_last_edited=\u00bbon|tablet\u00bb custom_css_main_element=\u00bbdisplay: grid;||align-content: center;\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.25.0&#8243; text_text_color=\u00bb#FFFFFF\u00bb custom_padding=\u00bb||||false|false\u00bb header_2_text_align_tablet=\u00bbcenter\u00bb header_2_text_align_phone=\u00bb\u00bb header_2_text_align_last_edited=\u00bbon|tablet\u00bb text_orientation_tablet=\u00bbcenter\u00bb text_orientation_phone=\u00bb\u00bb text_orientation_last_edited=\u00bbon|tablet\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h2>CHARLA SOBRE CALIDAD<\/h2>\n<p>Sanjay Banerjee, director de Operaciones de Potrero Medical, comparte sus ideas sobre las estrategias de calidad y cumplimiento normativo.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; _builder_version=\u00bb4.18.0&#8243; custom_margin=\u00bb||||false|false\u00bb custom_padding=\u00bb0px|||||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb0px||18px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text admin_label=\u00bbFACE AUDITS WITH CONFIDENCE\u00bb _builder_version=\u00bb4.18.0&#8243; header_2_text_align=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h2 style=\"text-align: center;\" class=\"dark-green\">ABORDAMIENTO DE AUDITOR\u00cdAS CON CONFIANZA<\/h2>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00bb1_2,1_2&#8243; use_custom_gutter=\u00bbon\u00bb gutter_width=\u00bb4&#8243; make_equal=\u00bbon\u00bb _builder_version=\u00bb4.16&#8243; custom_margin=\u00bb||50px||false|false\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_2&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_image src=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Face-Audits.jpg\u00bb alt=\u00bbAuditor\u00eda de dispositivos m\u00e9dicos\u00bb title_text=\u00bbFace-Audits\u00bb _builder_version=\u00bb4.18.0&#8243; global_colors_info=\u00bb{}\u00bb][\/et_pb_image][\/et_pb_column][et_pb_column type=\u00bb1_2&#8243; _builder_version=\u00bb4.16&#8243; custom_css_main_element=\u00bbdisplay: grid;||align-content: center;\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.16&#8243; header_4_text_align=\u00bbleft\u00bb custom_margin=\u00bb||0px||false|false\u00bb header_4_text_align_tablet=\u00bbright\u00bb header_4_text_align_phone=\u00bb\u00bb header_4_text_align_last_edited=\u00bbon|tablet\u00bb text_orientation_tablet=\u00bbright\u00bb text_orientation_phone=\u00bbleft\u00bb text_orientation_last_edited=\u00bbon|tablet\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><span>Arena QMS permite a los <a href=\"https:\/\/www.arenasolutions.com\/resources\/articles\/medical-device-development\/\">fabricantes de dispositivos m\u00e9dicos<\/a> de Clase I, II y III cumplir los requisitos de la FDA 21 CFR, Parte 820, Parte 11 e ISO 13485. Le ayudamos a obtener el control de su DMR, DHF, SOP y registros de formaci\u00f3n para superar favorablemente las auditor\u00edas internas o de la <a href=\"https:\/\/www.arenasolutions.com\/blog\/fdas-adoption-iso-13485-what-medical-device-manufacturers-should-know\/\">FDA<\/a>.<\/span><\/p>\n<p>[\/et_pb_text][et_pb_button button_url=\u00bb\/resources\/articles\/fda-audit-tips\/\u00bb button_text=\u00bb5\u00a0consejos para superar favorablemente las auditor\u00edas de la FDA o la ISO con confianza\u00bb module_class=\u00bblocale-hide-cn\u00bb _builder_version=\u00bb4.20.0&#8243; global_colors_info=\u00bb{}\u00bb][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; admin_label=\u00bbPurpose-built PLM\u00bb module_class=\u00bbquote-section\u00bb _builder_version=\u00bb4.18.0&#8243; background_image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/dark-purple-background.jpg\u00bb custom_padding=\u00bb19px||19px||true|\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row use_custom_gutter=\u00bbon\u00bb gutter_width=\u00bb1&#8243; make_equal=\u00bbon\u00bb _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb20px||20px||true|false\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb30px||30px|40px|true|false\u00bb custom_padding_tablet=\u00bb|||0px|false|false\u00bb custom_padding_phone=\u00bb\u00bb custom_padding_last_edited=\u00bbon|tablet\u00bb custom_css_main_element=\u00bbdisplay: grid;||align-content: center;\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.16&#8243; text_text_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb max_width=\u00bb985px\u00bb module_alignment=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><span>\u00abAunque el equipo de Arena no particip\u00f3 en nuestra inspecci\u00f3n de la FDA, su soluci\u00f3n nos ayud\u00f3 a encontrar y recuperar registros r\u00e1pidamente para cumplir los requisitos de la inspecci\u00f3n antes de lo previsto. \u00a1Gracias por cubrir nuestras necesidades y crear una soluci\u00f3n que realmente funciona tal y como prometieron!\u00bb<\/span><\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=\u00bb4.18.0&#8243; text_text_color=\u00bb#afb1ff\u00bb text_orientation=\u00bbcenter\u00bb custom_margin=\u00bb24px||||false|false\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><span style=\"color: #ffffff;\"><strong style=\"letter-spacing: 0 !important;\">Michelle J. Potvin&nbsp;&nbsp;<\/strong>ASQ CQA, directora, Garant\u00eda de calidad y asuntos normativos, Swan Valley Medical<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; module_id=\u00bbcustomer-logo-slider\u00bb _builder_version=\u00bb4.24.2&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.18.0&#8243; header_2_text_align=\u00bbcenter\u00bb text_orientation=\u00bbcenter\u00bb custom_margin=\u00bb||10px||false|false\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h2 style=\"text-align: center;\" class=\"dark-green\">\u00daNASE A ESTOS CLIENTES INNOVADORES<\/h2>\n<p>[\/et_pb_text][mt-divi-logo-slider images=\u00bb10033,10031,10032,10383,10029,10028,10021,10025,10023,10020,10026,13718,32928,67326&#8243; admin_label=\u00bbQMS Logo Slider\u00bb _builder_version=\u00bb4.27.4&#8243; _module_preset=\u00bbdefault\u00bb global_module=\u00bb10396&#8243; saved_tabs=\u00bball\u00bb global_colors_info=\u00bb{}\u00bb][\/mt-divi-logo-slider][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; admin_label=\u00bbQMS CTA &#8211; See Arena In Action\u00bb module_id=\u00bbbefore-footer-cta\u00bb module_class=\u00bbcta-section blue-button footer-cta-section\u00bb _builder_version=\u00bb4.24.2&#8243; background_image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/orange-bg.jpg\u00bb custom_padding=\u00bb30px||30px||true|\u00bb link_option_url=\u00bb\/qms-demo\/\u00bb global_module=\u00bb15757&#8243; saved_tabs=\u00bball\u00bb locked=\u00bboff\u00bb collapsed=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row column_structure=\u00bb1_2,1_2&#8243; use_custom_gutter=\u00bbon\u00bb gutter_width=\u00bb1&#8243; make_equal=\u00bbon\u00bb _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_2&#8243; _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb|40px|||false|false\u00bb custom_padding_tablet=\u00bb|0px|0px||false|false\u00bb custom_padding_phone=\u00bb\u00bb custom_padding_last_edited=\u00bbon|desktop\u00bb custom_css_main_element=\u00bbdisplay: grid;||align-content: center;\u00bb border_width_right=\u00bb1px\u00bb border_color_right=\u00bb#FFFFFF\u00bb border_width_all_tablet=\u00bb\u00bb border_width_all_phone=\u00bb\u00bb border_width_all_last_edited=\u00bbon|desktop\u00bb border_width_right_tablet=\u00bb0px\u00bb border_width_right_phone=\u00bb\u00bb border_width_right_last_edited=\u00bbon|tablet\u00bb global_colors_info=\u00bb{}\u00bb custom_css_main_element_last_edited=\u00bbon|tablet\u00bb custom_css_main_element_tablet=\u00bbpadding-bottom: 0 !important;\u00bb custom_css_main_element_phone=\u00bbpadding-bottom: 0 !important;\u00bb][et_pb_text _builder_version=\u00bb4.16&#8243; header_2_text_align=\u00bbright\u00bb header_2_text_color=\u00bb#FFFFFF\u00bb header_2_font_size=\u00bb36px\u00bb custom_padding=\u00bb||||false|true\u00bb header_2_text_align_tablet=\u00bbcenter\u00bb header_2_text_align_phone=\u00bbcenter\u00bb header_2_text_align_last_edited=\u00bbon|tablet\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h2>VER Arena<br \/> <span style=\"font-family: 'acier-bat-outline';\">EN ACCI\u00d3N<\/span><\/h2>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_2&#8243; 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Simplificamos el cumplimiento normativo de FDA 21 CFR, Parte 820 e ISO 13485. Arena centraliza el control de los procedimientos operativos est\u00e1ndar (SOP), los archivos de historial de dispositivos (DHF), los registros de dispositivos maestros (DMR), los registros de formaci\u00f3n y mucho m\u00e1s.\" \/>\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.arenasolutions.com\/es\/solutions\/compliance-management\/medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cumplimiento normativo sobre dispositivos m\u00e9dicos\" \/>\n<meta property=\"og:description\" content=\"El software Arena QMS le ayuda a alcanzar el cumplimiento de las normativas FDA e ISO. Simplificamos el cumplimiento normativo de FDA 21 CFR, Parte 820 e ISO 13485. 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