{"id":36676,"date":"2023-09-08T08:23:28","date_gmt":"2023-09-08T15:23:28","guid":{"rendered":"https:\/\/www.arenasolutions.com\/controles-de-diseno-soluciones\/"},"modified":"2026-04-09T09:02:25","modified_gmt":"2026-04-09T16:02:25","slug":"controles-de-diseno-soluciones","status":"publish","type":"page","link":"https:\/\/www.arenasolutions.com\/es\/solutions\/design-controls\/","title":{"rendered":"Controles de dise\u00f1o (soluciones)"},"content":{"rendered":"<p>[et_pb_section fb_built=\u00bb1&#8243; admin_label=\u00bbHero-Text\u00bb module_class=\u00bbas-db-hero-tier-3&#8243; _builder_version=\u00bb4.27.5&#8243; _module_preset=\u00bbdefault\u00bb background_color=\u00bb#FFFFFF\u00bb use_background_color_gradient=\u00bbon\u00bb background_color_gradient_stops=\u00bb#ffffff 50%|rgba(61,70,71,0.15) 100%\u00bb background_color_gradient_overlays_image=\u00bbon\u00bb background_color_gradient_start=\u00bbrgba(27,31,37,0.3)\u00bb background_color_gradient_end=\u00bb#1b1f25&#8243; background_enable_image=\u00bboff\u00bb custom_padding=\u00bb||31px|||\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.27.5&#8243; _module_preset=\u00bbdefault\u00bb custom_padding=\u00bb0px||0px||false|false\u00bb hover_enabled=\u00bb0&#8243; global_colors_info=\u00bb{}\u00bb custom_margin=\u00bb||70px||false|false\u00bb sticky_enabled=\u00bb0&#8243;][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.27.5&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_text admin_label=\u00bbTitle\u00bb _builder_version=\u00bb4.27.5&#8243; _module_preset=\u00bbdefault\u00bb header_text_align=\u00bbleft\u00bb header_font_size=\u00bb80px\u00bb header_letter_spacing=\u00bb1px\u00bb header_line_height=\u00bb1.1em\u00bb header_2_letter_spacing=\u00bb1px\u00bb header_2_line_height=\u00bb1.1em\u00bb custom_margin=\u00bb2px||13px||false|false\u00bb header_text_align_tablet=\u00bbcenter\u00bb header_text_align_phone=\u00bbcenter\u00bb header_text_align_last_edited=\u00bbon|phone\u00bb header_font_size_tablet=\u00bb55px\u00bb header_font_size_phone=\u00bb30px\u00bb header_font_size_last_edited=\u00bbon|phone\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h1>Controles de dise\u00f1o <\/h1>\n<p>[\/et_pb_text][et_pb_text _builder_version=\u00bb4.27.5&#8243; _module_preset=\u00bbdefault\u00bb text_font=\u00bb|600|||||||\u00bb text_text_color=\u00bb#00890b\u00bb text_letter_spacing=\u00bb1px\u00bb text_line_height=\u00bb1.5em\u00bb text_font_size_tablet=\u00bb30px\u00bb text_font_size_phone=\u00bb20px\u00bb text_font_size_last_edited=\u00bbon|phone\u00bb text_line_height_tablet=\u00bb1.4em\u00bb text_line_height_phone=\u00bb1.3em\u00bb text_line_height_last_edited=\u00bbon|desktop\u00bb text_orientation_tablet=\u00bbcenter\u00bb text_orientation_phone=\u00bbcenter\u00bb text_orientation_last_edited=\u00bbon|desktop\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h4>Impulso de la conformidad <br class=\"hidden-on-mobile\" \/>Controles de dise\u00f1o de productos <\/h4>\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=\u00bb2&#8243; make_equal=\u00bbon\u00bb disabled_on=\u00bboff|off|off\u00bb module_class=\u00bbleft-right-blurbs-row\u00bb _builder_version=\u00bb4.27.5&#8243; _module_preset=\u00bbdefault\u00bb custom_padding=\u00bb50px||0px||false|false\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_2&#8243; _builder_version=\u00bb4.25.1&#8243; _module_preset=\u00bbdefault\u00bb hover_enabled=\u00bb0&#8243; custom_css_main_element=\u00bbdisplay: grid;||align-content: center;||\u00bb global_colors_info=\u00bb{}\u00bb sticky_enabled=\u00bb0&#8243;][et_pb_image src=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/FDA-Design-Dev-Process-Flow-ES.png\u00bb alt=\u00bbDiagrama de elementos clave de controles de dise\u00f1o\u00bb title_text=\u00bbFDA-Design-Dev-Process-Flow\u00bb _builder_version=\u00bb4.27.5&#8243; max_width=\u00bb600px\u00bb hover_enabled=\u00bb0&#8243; locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb sticky_enabled=\u00bb0&#8243;][\/et_pb_image][\/et_pb_column][et_pb_column type=\u00bb1_2&#8243; _builder_version=\u00bb4.27.5&#8243; _module_preset=\u00bbdefault\u00bb custom_css_main_element=\u00bbdisplay: grid;||align-content: center;||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_text content_tablet=\u00bb<\/p>\n<h2 style=%22text-align: center;%22>Gain Market Advantage With Compliant Product Development<\/h2>\n<p style=%22text-align: center;%22>The aerospace and defense market demands quality, product development efficiency, technological innovation, and regulatory compliance.<\/p>\n<p style=%22text-align: center;%22>Arena PLM for AWS GovCloud is the proven cloud product development solution for regulated companies requiring a secure platform to manage their product and quality information and meet regulatory requirements.<\/p>\n<p>\u00bb content_phone=\u00bb<\/p>\n<h2 style=%22text-align: center;%22>Gain Market Advantage With Compliant Product Development<\/h2>\n<p style=%22text-align: center;%22>The aerospace and defense market demands quality, product development efficiency, technological innovation, and regulatory compliance.<\/p>\n<p style=%22text-align: center;%22>Arena PLM for AWS GovCloud is the proven cloud product development solution for regulated companies requiring a secure platform to manage their product and quality information and meet regulatory requirements.<\/p>\n<p>\u00bb content_last_edited=\u00bbon|phone\u00bb admin_label=\u00bbIntro\u00bb _builder_version=\u00bb4.27.5&#8243; _module_preset=\u00bbdefault\u00bb custom_margin=\u00bb||30px||false|false\u00bb hover_enabled=\u00bb0&#8243; locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb sticky_enabled=\u00bb0&#8243;]<\/p>\n<p><span>Las empresas de dispositivos m\u00e9dicos y sus cadenas de suministro est\u00e1n m\u00e1s dispersas que nunca. Todos los implicados en el desarrollo e introducci\u00f3n de nuevos productos (NPDI) necesitan compartir, revisar y utilizar la informaci\u00f3n m\u00e1s reciente sobre productos y su calidad para garantizar que los productos seguros y eficaces puedan fabricarse tal y como se dise\u00f1aron. Adem\u00e1s, todos los procesos deben cumplir con la FDA y otros organismos reguladores. <\/span><\/p>\n<p><span>Arena administra los elementos clave de los <a href=\"https:\/\/www.arenasolutions.com\/white-papers\/strong-design-controls\/\">controles de dise\u00f1o<\/a> al tiempo que acelera la innovaci\u00f3n. Sus equipos de calidad, ingenier\u00eda y operaciones pueden establecer, documentar y seguir r\u00e1pidamente procedimientos conformes a la normativa.<\/span><\/p>\n<p>[\/et_pb_text][et_pb_button button_url=\u00bb\/white-papers\/strong-design-controls\/\u00bb url_new_window=\u00bbon\u00bb button_text=\u00bbM\u00e1s informaci\u00f3n\u00bb button_alignment=\u00bbleft\u00bb button_alignment_tablet=\u00bbcenter\u00bb button_alignment_phone=\u00bbcenter\u00bb button_alignment_last_edited=\u00bbon|phone\u00bb _builder_version=\u00bb4.27.5&#8243; _module_preset=\u00bb67e2fde8-ec43-47ca-aa81-f27e635671cb\u00bb custom_margin=\u00bb0px||||false|false\u00bb locked=\u00bboff\u00bb 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=\u00bbEXPLORE ARENA&#8217;S COMPREHENSIVE PLM PLATFORM\u00bb _builder_version=\u00bb4.16&#8243; background_color=\u00bb#FFFFFF\u00bb use_background_color_gradient=\u00bbon\u00bb background_color_gradient_stops=\u00bb#ffffff 50%|rgba(61,70,71,0.15) 100%\u00bb background_color_gradient_overlays_image=\u00bbon\u00bb background_color_gradient_start=\u00bbrgba(27,31,37,0.3)\u00bb background_color_gradient_end=\u00bb#1b1f25&#8243; background_enable_image=\u00bboff\u00bb custom_padding=\u00bb100px||30px|||\u00bb top_divider_style=\u00bbarrow\u00bb top_divider_color=\u00bbrgba(61,70,71,0.15)\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=\u00bb4.27.5&#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;\">Unos controles de dise\u00f1o eficaces aumentan su confianza al abordar una auditor\u00eda<\/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=\u00bb4.27.5&#8243; text_orientation=\u00bbcenter\u00bb module_alignment=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><span>El desarrollo de dispositivos m\u00e9dicos requiere el cumplimiento de las normativas FDA, EMA, ISO y otras.&nbsp;<\/span><span>Las funciones de control del dise\u00f1o de Arena simplifican sus procesos de revisi\u00f3n, verificaci\u00f3n y validaci\u00f3n. <a href=\"https:\/\/www.arenasolutions.com\/es\/platform\/qms\/\">Arena QMS<\/a> acelera los cambios y transferencias de dise\u00f1o estableciendo los elementos de control del dise\u00f1o y realizando un seguimiento de estos: necesidades del usuario, aportes de dise\u00f1o, procesos de dise\u00f1o, resultados de dise\u00f1o y documentaci\u00f3n del dispositivo.&nbsp;<\/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 module_class=\u00bbfive-column-boxes white-boxes-row\u00bb _builder_version=\u00bb4.16&#8243; max_width=\u00bb1200px\u00bb module_alignment=\u00bbcenter\u00bb custom_padding=\u00bb0px||35px||false|false\u00bb custom_css_main_element=\u00bbmax-width: 990px !important;\u00bb locked=\u00bboff\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=\u00bbquality teams icon\u00bb image_icon_width=\u00bb40%\u00bb _builder_version=\u00bb4.27.5&#8243; header_level=\u00bbh3&#8243; header_font=\u00bb|700|||||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#3d4647&#8243; background_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb height=\u00bb100%\u00bb custom_padding=\u00bb30px|20px|30px|20px|true|true\u00bb border_radii=\u00bbon|20px|20px|20px|20px\u00bb border_width_all=\u00bb1px\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h4><span style=\"color: #00890b;\">LOS EQUIPOS<br \/>DE CALIDAD<\/span><\/h4>\n<p>vinculan los procesos de medidas correctoras y preventivas (CAPA) con el registro del producto para cerrar el proceso calidad-producto<\/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 image_icon_width=\u00bb40%\u00bb _builder_version=\u00bb4.27.5&#8243; header_level=\u00bbh3&#8243; header_font=\u00bb|700|||||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#3d4647&#8243; background_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb height=\u00bb100%\u00bb custom_padding=\u00bb30px|20px|30px|20px|true|true\u00bb border_radii=\u00bbon|20px|20px|20px|20px\u00bb border_width_all=\u00bb1px\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h4><span style=\"color: #00890b;\">LOS EQUIPOS DE CUMPLIMIENTO DE LA NORMATIVA<\/span><\/h4>\n<p>demuestran que se han establecido y seguido procesos de control del dise\u00f1o<\/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-DESIGN-TEAMS.svg\u00bb alt=\u00bbIcon-DESIGN TEAMS\u00bb image_icon_width=\u00bb40%\u00bb _builder_version=\u00bb4.27.5&#8243; header_level=\u00bbh3&#8243; header_font=\u00bb|700|||||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#3d4647&#8243; background_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb height=\u00bb100%\u00bb custom_padding=\u00bb30px|20px|30px|20px|true|true\u00bb border_radii=\u00bbon|20px|20px|20px|20px\u00bb border_width_all=\u00bb1px\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h4><span style=\"color: #00890b;\">LOS EQUIPOS DE<\/span><br \/><span style=\"color: #00890b;\">DISE\u00d1O<\/span><\/h4>\n<p>crean, modifican y comparten los \u00faltimos resultados de dise\u00f1o para su revisi\u00f3n, verificaci\u00f3n y validaci\u00f3n<\/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=\u00bb2&#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=\u00bb0px||35px||false|false\u00bb custom_css_main_element=\u00bbmax-width: 990px !important;\u00bb locked=\u00bboff\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-IT-System-Admins.svg\u00bb alt=\u00bbIcon-IT-System-Admins\u00bb image_icon_width=\u00bb40%\u00bb _builder_version=\u00bb4.27.5&#8243; header_level=\u00bbh3&#8243; header_font=\u00bb|700|||||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#3d4647&#8243; background_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb height=\u00bb100%\u00bb custom_padding=\u00bb30px|20px|30px|20px|true|true\u00bb border_radii=\u00bbon|20px|20px|20px|20px\u00bb border_width_all=\u00bb1px\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h4><span style=\"color: #00890b;\">LA INGENIER\u00cdA <br \/>DE SISTEMAS<\/span><\/h4>\n<p>administra las necesidades din\u00e1micas de los usuarios como requisitos y las vincula con los aportes y resultados del dise\u00f1o<\/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-SUPPLY-CHAIN-PARTNERS.svg\u00bb alt=\u00bbIcon-SUPPLY CHAIN PARTNERS\u00bb image_icon_width=\u00bb40%\u00bb _builder_version=\u00bb4.27.5&#8243; header_level=\u00bbh3&#8243; header_font=\u00bb|700|||||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#3d4647&#8243; background_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb height=\u00bb100%\u00bb custom_padding=\u00bb30px|20px|30px|20px|true|true\u00bb border_radii=\u00bbon|20px|20px|20px|20px\u00bb border_width_all=\u00bb1px\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h4><span style=\"color: #00890b;\">LOS SOCIOS DE LA CADENA DE SUMINISTRO<\/span><\/h4>\n<p>disponen de controles basados en roles para revisar y aprobar de forma segura las versiones y los cambios de los productos<\/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-PROCUREMENT-TEAMS.svg\u00bb alt=\u00bbIcon-PROCUREMENT TEAMS\u00bb image_icon_width=\u00bb40%\u00bb _builder_version=\u00bb4.27.5&#8243; header_level=\u00bbh3&#8243; header_font=\u00bb|700|||||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#3d4647&#8243; background_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb height=\u00bb100%\u00bb custom_padding=\u00bb30px|20px|30px|20px|true|true\u00bb border_radii=\u00bbon|20px|20px|20px|20px\u00bb border_width_all=\u00bb1px\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h4><span style=\"color: #00890b;\">LOS EQUIPOS DE<br \/>DE OPERACIONES<\/span><\/h4>\n<p>revisan y analizan los dise\u00f1os de productos propuestos para el an\u00e1lisis de DFM<\/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; background_color=\u00bb#FFFFFF\u00bb use_background_color_gradient=\u00bbon\u00bb background_color_gradient_stops=\u00bb#ffffff 50%|rgba(61,70,71,0.15) 100%\u00bb background_color_gradient_overlays_image=\u00bbon\u00bb background_color_gradient_start=\u00bbrgba(27,31,37,0.3)\u00bb background_color_gradient_end=\u00bb#1b1f25&#8243; background_enable_image=\u00bboff\u00bb custom_padding=\u00bb100px||5px|||\u00bb top_divider_style=\u00bbarrow\u00bb top_divider_color=\u00bbrgba(61,70,71,0.15)\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb51px||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=\u00bb4.27.5&#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\">Elimine los procesos manuales y las hojas de c\u00e1lculo sin conexi\u00f3n entre s\u00ed<\/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>Arena optimiza la administraci\u00f3n de art\u00edculos y de LDM para acelerar el dise\u00f1o y la entrega de productos innovadores.<\/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; _builder_version=\u00bb4.27.4&#8243; _module_preset=\u00bb41dffb06-5c20-4d40-9217-99f1a757f6bd\u00bb custom_padding=\u00bb20px||32px|||\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_3&#8243; _builder_version=\u00bb4.27.4&#8243; _module_preset=\u00bbdefault\u00bb custom_padding=\u00bb||||false|false\u00bb custom_padding_tablet=\u00bb||||false|false\u00bb custom_padding_phone=\u00bb||30px||false|false\u00bb custom_padding_last_edited=\u00bbon|phone\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_blurb image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Ensures-Regulatory-Compliance.jpg\u00bb alt=\u00bbImage-Compliance concept on a laptop screen\u00bb _builder_version=\u00bb4.27.5&#8243; header_level=\u00bbh3&#8243; header_font=\u00bb|700||on|||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#00890B\u00bb header_font_size=\u00bb20px\u00bb header_line_height=\u00bb1.2em\u00bb body_font=\u00bb|700||on|||||\u00bb body_text_align=\u00bbcenter\u00bb body_text_color=\u00bb#3D4647&#8243; body_font_size=\u00bb26px\u00bb body_line_height=\u00bb1.2em\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p style=\"text-align: center;\">Descubra la confianza en las auditor\u00edas<\/p>\n<p>[\/et_pb_blurb][et_pb_toggle title=\u00bbC\u00f3mo le ayuda Arena\u00bb icon_color=\u00bb#00890B\u00bb open_icon_color=\u00bb#3D4647&#8243; _builder_version=\u00bb4.27.5&#8243; title_text_color=\u00bb#3D4647&#8243; title_level=\u00bbh3&#8243; title_font=\u00bb|||on|||||\u00bb title_font_size=\u00bb18px\u00bb title_letter_spacing=\u00bb1px\u00bb closed_title_font_size=\u00bb18px\u00bb closed_title_letter_spacing=\u00bb1px\u00bb body_line_height=\u00bb1.3em\u00bb background_color=\u00bb#FFFFFF\u00bb custom_margin=\u00bb0px||0px||false|false\u00bb custom_padding=\u00bb10px||10px||false|false\u00bb border_color_all=\u00bb#c5c6cb\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<ul>\n<li><span>Arena permite el cumplimiento normativo de los controles de dise\u00f1o<\/span><\/li>\n<li><span>Los auditores pueden encontrar f\u00e1cilmente pruebas de que se han establecido, documentado y seguido procesos conformes a la normativa<br \/> <\/span><\/li>\n<\/ul>\n<p>[\/et_pb_toggle][\/et_pb_column][et_pb_column type=\u00bb1_3&#8243; _builder_version=\u00bb4.27.4&#8243; _module_preset=\u00bbdefault\u00bb custom_padding_tablet=\u00bb\u00bb custom_padding_phone=\u00bb||30px||false|false\u00bb custom_padding_last_edited=\u00bbon|phone\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_blurb image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Reduces-Confusion-Mistakes.jpg\u00bb alt=\u00bbImage-Conceptual image of a folder with a keyhole integrated on a circuit board, suggesting data protection &#038; information security\u00bb _builder_version=\u00bb4.27.5&#8243; header_level=\u00bbh3&#8243; header_font=\u00bb|700||on|||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#00890B\u00bb header_font_size=\u00bb20px\u00bb header_line_height=\u00bb1.2em\u00bb body_font=\u00bb|700||on|||||\u00bb body_text_align=\u00bbcenter\u00bb body_text_color=\u00bb#3D4647&#8243; body_font_size=\u00bb26px\u00bb body_line_height=\u00bb1.2em\u00bb custom_padding=\u00bb||0px|||\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p style=\"text-align: center;\">Reduce la confusi\u00f3n<br \/>y los errores<\/p>\n<p>[\/et_pb_blurb][et_pb_toggle title=\u00bbC\u00f3mo le ayuda Arena\u00bb icon_color=\u00bb#00890B\u00bb open_icon_color=\u00bb#3D4647&#8243; _builder_version=\u00bb4.27.5&#8243; title_text_color=\u00bb#3D4647&#8243; title_level=\u00bbh3&#8243; title_font=\u00bb|||on|||||\u00bb title_font_size=\u00bb18px\u00bb title_letter_spacing=\u00bb1px\u00bb closed_title_font_size=\u00bb18px\u00bb closed_title_letter_spacing=\u00bb1px\u00bb body_line_height=\u00bb1.3em\u00bb background_color=\u00bb#FFFFFF\u00bb custom_margin=\u00bb0px||0px||false|false\u00bb custom_padding=\u00bb10px||10px||false|false\u00bb border_color_all=\u00bb#c5c6cb\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<ul>\n<li><span>La calidad y el dise\u00f1o conectados se extienden a lo largo de toda la cadena de suministro y esto reduce los retos que crean los equipos dispersos<br \/> <\/span><\/li>\n<li><span>Centralizar la LDM, el DHF y el DMR con el dise\u00f1o del producto asociado y los registros de calidad mantiene a todos en sinton\u00eda<br \/> <\/span><\/li>\n<\/ul>\n<p>[\/et_pb_toggle][\/et_pb_column][et_pb_column type=\u00bb1_3&#8243; _builder_version=\u00bb4.27.4&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_blurb image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Control-Access-Design.jpg\u00bb alt=\u00bbImage-Abstract network grid with files and folders, futuristic software interface, digital document management system, store, search and organize documents\u00bb _builder_version=\u00bb4.27.5&#8243; header_level=\u00bbh3&#8243; header_font=\u00bb|700||on|||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#00890B\u00bb header_font_size=\u00bb20px\u00bb header_line_height=\u00bb1.2em\u00bb body_font=\u00bb|700||on|||||\u00bb body_text_align=\u00bbcenter\u00bb body_text_color=\u00bb#3D4647&#8243; body_font_size=\u00bb26px\u00bb body_line_height=\u00bb1.2em\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p style=\"text-align: center;\">Control del acceso a<br \/>Todo su dise\u00f1o<\/p>\n<p>[\/et_pb_blurb][et_pb_toggle title=\u00bbC\u00f3mo le ayuda Arena\u00bb icon_color=\u00bb#00890B\u00bb open_icon_color=\u00bb#3D4647&#8243; _builder_version=\u00bb4.27.5&#8243; title_text_color=\u00bb#3D4647&#8243; title_level=\u00bbh3&#8243; title_font=\u00bb|||on|||||\u00bb title_font_size=\u00bb18px\u00bb title_letter_spacing=\u00bb1px\u00bb closed_title_font_size=\u00bb18px\u00bb closed_title_letter_spacing=\u00bb1px\u00bb body_line_height=\u00bb1.3em\u00bb background_color=\u00bb#FFFFFF\u00bb custom_margin=\u00bb0px||0px||false|false\u00bb custom_padding=\u00bb10px||10px||false|false\u00bb border_color_all=\u00bb#c5c6cb\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<ul>\n<li><span>La informaci\u00f3n sobre art\u00edculos y LDM controlados por revisiones est\u00e1 vinculada a cambios de ingenier\u00eda, acciones de calidad, fabricantes y proveedores relacionados<br \/> <\/span><\/li>\n<li><span>Cree, modifique y comparta de forma segura dise\u00f1os de productos con Calidad, Operaciones y proveedores para su revisi\u00f3n interdisciplinaria<br \/> <\/span><\/li>\n<\/ul>\n<p>[\/et_pb_toggle][\/et_pb_column][\/et_pb_row][et_pb_row module_class=\u00bblocale-hide-cn \u00bb _builder_version=\u00bb4.22.0&#8243; custom_padding=\u00bb29px||4px|||\u00bb locked=\u00bboff\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=\u00bb4.27.5&#8243; text_orientation=\u00bbcenter\u00bb custom_margin=\u00bb||30px||false|false\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><span>Descubra c\u00f3mo unos controles de dise\u00f1o s\u00f3lidos simplifican el cumplimiento y eliminan la inquietud por la auditor\u00eda.<\/span><\/p>\n<p>[\/et_pb_text][et_pb_button button_url=\u00bb\/white-papers\/strong-design-controls\/\u00bb button_text=\u00bbLeer la documentaci\u00f3n t\u00e9cnica\u00bb button_alignment=\u00bbcenter\u00bb _builder_version=\u00bb4.27.5&#8243; _module_preset=\u00bb67e2fde8-ec43-47ca-aa81-f27e635671cb\u00bb global_colors_info=\u00bb{}\u00bb][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; _builder_version=\u00bb4.16&#8243; background_color=\u00bb#FFFFFF\u00bb use_background_color_gradient=\u00bbon\u00bb background_color_gradient_stops=\u00bb#ffffff 50%|rgba(61,70,71,0.15) 100%\u00bb background_color_gradient_overlays_image=\u00bbon\u00bb background_color_gradient_start=\u00bbrgba(27,31,37,0.3)\u00bb background_color_gradient_end=\u00bb#1b1f25&#8243; background_enable_image=\u00bboff\u00bb custom_padding=\u00bb100px||30px|||\u00bb top_divider_style=\u00bbarrow\u00bb top_divider_color=\u00bbrgba(61,70,71,0.15)\u00bb global_colors_info=\u00bb{}\u00bb][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\/Webinar-Establish-Compliant-Design-Controls.jpg\u00bb alt=\u00bbImagen: primer fotograma de un v\u00eddeo que muestra una diapositiva de PowerPoint titulada: Expertos en calidad comparten las claves para el \u00e9xito en los controles de dise\u00f1o de dispositivos m\u00e9dicos\u00bb title_text=\u00bbSeminario web: Establecimiento de controles de dise\u00f1o conformes a la normativa\u00bb _builder_version=\u00bb4.27.5&#8243; border_radii=\u00bbon|20px|20px|20px|20px\u00bb border_width_all=\u00bb1px\u00bb border_color_all=\u00bb#617480&#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=\u00bb4.27.5&#8243; header_4_text_align=\u00bbleft\u00bb custom_margin=\u00bb||30px||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>Las empresas de dispositivos m\u00e9dicos saben que unos controles de dise\u00f1o eficaces dan lugar a productos de alta calidad. Con Arena, sus equipos de producto pueden establecer, documentar y seguir controles de dise\u00f1o conformes a la normativa. Esto permite que todo el equipo pueda ver sus registros de productos y calidad. Arena QMS proporciona los controles de dise\u00f1o necesarios para ayudarle a suministrar r\u00e1pidamente dispositivos m\u00e9dicos innovadores y conformes a la normativa. <\/span><\/p>\n<p>[\/et_pb_text][et_pb_button button_url=\u00bb\/resources\/plm-webinars\/quality-experts-share-keys-to-medical-device-design-controls-success\/\u00bb button_text=\u00bbVer el seminario web\u00bb module_class=\u00bblocale-hide-cn\u00bb _builder_version=\u00bb4.27.5&#8243; _module_preset=\u00bb67e2fde8-ec43-47ca-aa81-f27e635671cb\u00bb 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=\u00bbQuote\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=\u00bb4.27.5&#8243; text_text_color=\u00bb#FFFFFF\u00bb text_font_size=\u00bb24px\u00bb text_orientation=\u00bbcenter\u00bb max_width=\u00bb985px\u00bb module_alignment=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><span>\u00abIncorporamos la administraci\u00f3n de riesgos en todo el proceso de controles de dise\u00f1o seg\u00fan 21 CFR, Parte 820.30. La administraci\u00f3n de riesgos comienza en una fase temprana del proceso de dise\u00f1o, cuando se definen las necesidades de los usuarios y las caracter\u00edsticas del dise\u00f1o. Esta identificaci\u00f3n temprana de los riesgos nos ayuda a administrar y ofrecer resultados satisfactorios de verificaci\u00f3n y validaci\u00f3n del dise\u00f1o\u00bb.<\/span><\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=\u00bb4.27.5&#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;\">Vis Ayer&nbsp;&nbsp;<\/strong>director s\u00e9nior, Nevro<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; _builder_version=\u00bb4.27.5&#8243; custom_padding=\u00bb30px||29px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb29px|||||\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=\u00bb4.27.5&#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=\u00bb9990,9994,9992,9982,9988,9993,9986,9991,11521,9983,10383,9996,9987,9984,35743&#8243; admin_label=\u00bbBrand Logo Slider\u00bb _builder_version=\u00bb4.22.1&#8243; _module_preset=\u00bbdefault\u00bb custom_margin=\u00bb||35px||false|false\u00bb custom_padding=\u00bb||||false|false\u00bb global_module=\u00bb10430&#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=\u00bbSee Arena In Action\u00bb module_class=\u00bbas-db-section-global-footer-cta\u00bb _builder_version=\u00bb4.27.4&#8243; _module_preset=\u00bbc8e9298d-2575-47d5-a568-ecf944bc8036&#8243; 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