{"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":"2026-07-13T09:14:56","modified_gmt":"2026-07-13T16:14:56","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":"

[et_pb_section fb_built=\u00bb1″ admin_label=\u00bbHero-Text\u00bb module_class=\u00bbas-db-hero-tier-3″ _builder_version=\u00bb4.27.5″ _module_preset=\u00bbdefault\u00bb background_color=\u00bb#FFFFFF\u00bb use_background_color_gradient=\u00bbon\u00bb background_color_gradient_stops=\u00bb#ffffff 50%|#e1e2e3 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″ 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″ _module_preset=\u00bbdefault\u00bb custom_padding=\u00bb4px||6px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4″ _builder_version=\u00bb4.27.5″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_text admin_label=\u00bbTitle\u00bb _builder_version=\u00bb4.27.5″ _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

Auditor\u00eda de dispositivos m\u00e9dicos<\/h1>\n

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Simplificaci\u00f3n del cumplimiento normativo de FDA, EU MDR e ISO<\/h3>\n

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Agilizaci\u00f3n de la preparaci\u00f3n para el cumplimiento de normativas y requisitos<\/h2>\n

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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 FDA<\/a>, la EU MDR<\/a>, la 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\n

El software QMS basado en la nube de Arena le ayuda a conseguir y mantener s\u00f3lidos 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

\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1″ admin_label=\u00bbEXPLORE ARENA’S COMPREHENSIVE PLM PLATFORM\u00bb _builder_version=\u00bb4.16″ background_color=\u00bb#FFFFFF\u00bb use_background_color_gradient=\u00bbon\u00bb background_color_gradient_stops=\u00bb#ffffff 50%|#e1e2e3 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″ background_enable_image=\u00bboff\u00bb custom_margin=\u00bb0px||0px||false|false\u00bb custom_padding=\u00bb100px||0px||false|false\u00bb top_divider_style=\u00bbarrow\u00bb top_divider_color=\u00bb#e1e2e3″ global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.16″ custom_padding=\u00bb||0px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4″ _builder_version=\u00bb4.16″ global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.27.5″ text_text_color=\u00bb#FFFFFF\u00bb header_2_text_align=\u00bbcenter\u00bb header_2_text_color=\u00bb#000000″ text_orientation=\u00bbcenter\u00bb custom_margin=\u00bb||0px|||\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n

La soluci\u00f3n de QMS en la nube simplifica el cumplimiento de la normativa<\/h2>\n

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Introducir un 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. <\/span>El software 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

\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00bb1_3,1_3,1_3″ use_custom_gutter=\u00bbon\u00bb gutter_width=\u00bb2″ make_equal=\u00bbon\u00bb module_class=\u00bbfive-column-boxes white-boxes-row\u00bb _builder_version=\u00bb4.16″ max_width=\u00bb1200px\u00bb module_alignment=\u00bbcenter\u00bb custom_padding=\u00bb0px||35px||false|false\u00bb custom_css_main_element=\u00bbmax-width: 990px !important;\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_3″ _builder_version=\u00bb4.16″ global_colors_info=\u00bb{}\u00bb][et_pb_blurb image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-QUALITY-TEAMS.svg\u00bb alt=\u00bbQuality Assurance icon\u00bb image_icon_width=\u00bb40%\u00bb _builder_version=\u00bb4.27.5″ header_level=\u00bbh3″ header_font=\u00bb|700|||||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#3d4647″ background_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb height=\u00bb100%\u00bb custom_padding=\u00bb30px|20px|30px|20px|true|true\u00bb hover_enabled=\u00bb0″ border_radii=\u00bbon|20px|20px|20px|20px\u00bb border_width_all=\u00bb1px\u00bb global_colors_info=\u00bb{}\u00bb sticky_enabled=\u00bb0″]<\/p>\n

LOS EQUIPOS DE<\/span>
GARANT\u00cdA DE CALIDAD<\/span><\/h4>\n\n

siguen procesos cerrados de calidad<\/a> para mejorar la trazabilidad<\/p>\n

\n[\/et_pb_blurb][\/et_pb_column][et_pb_column type=\u00bb1_3″ _builder_version=\u00bb4.16″ 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″ header_level=\u00bbh3″ header_font=\u00bb|700|||||||\u00bb header_text_align=\u00bbcenter\u00bb header_text_color=\u00bb#3d4647″ background_color=\u00bb#FFFFFF\u00bb text_orientation=\u00bbcenter\u00bb height=\u00bb100%\u00bb custom_padding=\u00bb30px|20px|30px|20px|true|true\u00bb hover_enabled=\u00bb0″ border_radii=\u00bbon|20px|20px|20px|20px\u00bb border_width_all=\u00bb1px\u00bb global_colors_info=\u00bb{}\u00bb sticky_enabled=\u00bb0″]<\/p>\n

LOS EQUIPOS DE<\/span>
ASUNTOS NORMATIVOS<\/span><\/h4>\n\n

establecen s\u00f3lidos controles de dise\u00f1o y garantizan el cumplimiento de la normativa<\/p>\n

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LOS EQUIPOS DE<\/span>
ADMINISTRACI\u00d3N<\/span><\/h4>\n\n

mejoran el cumplimiento de los registros de formaci\u00f3n,<\/a> los SOP y mucho m\u00e1s<\/p>\n

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LOS EQUIPOS
DE INGENIER\u00cdA<\/span><\/h4>\n\n

obtienen visibilidad para seguir mejorando los dise\u00f1os conformes a la normativa <\/span><\/p>\n

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EL EQUIPO DE CONTROL<\/span>
DE DOCUMENTOS<\/span><\/h4>\n\n

puede preparar y superar favorablemente auditor\u00edas de la FDA<\/a>, ISO, EU MDR o internas<\/p>\n

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LOS EQUIPOS DE ADMINISTRACI\u00d3N EJECUTIVA<\/span><\/h4>\n\n

pueden tomar mejores decisiones para acelerar la comercializaci\u00f3n<\/p>\n

\n[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1″ _builder_version=\u00bb4.16″ background_color=\u00bb#FFFFFF\u00bb use_background_color_gradient=\u00bbon\u00bb background_color_gradient_stops=\u00bb#ffffff 50%|#e1e2e3 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″ background_enable_image=\u00bboff\u00bb custom_margin=\u00bb0px||0px||false|false\u00bb custom_padding=\u00bb100px||0px||false|false\u00bb top_divider_style=\u00bbarrow\u00bb top_divider_color=\u00bb#e1e2e3″ global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.16″ custom_padding=\u00bb||15px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4″ _builder_version=\u00bb4.16″ global_colors_info=\u00bb{}\u00bb][et_pb_text admin_label=\u00bbH2″ _builder_version=\u00bb4.18.0″ header_2_text_align=\u00bbcenter\u00bb custom_margin=\u00bb||17px|||\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n

PROCESOS DE CALIDAD CONECTADOS<\/h2>\n

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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).
<\/span><\/p>\n

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Optimiza los procesos de calidad de bucle cerrado<\/p>\n

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    \n
  • 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
  • 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

    \n[\/et_pb_toggle][\/et_pb_column][et_pb_column type=\u00bb1_3″ _builder_version=\u00bb4.27.4″ _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\/Streamline-Audits.jpg\u00bb alt=\u00bbImage-Engineer\/scientist using tablet in lab setting\u00bb _builder_version=\u00bb4.27.5″ header_level=\u00bbh3″ 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″ 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

    Reduce los riesgos de auditor\u00eda interna y externa<\/p>\n

    \n[\/et_pb_blurb][et_pb_toggle title=\u00bbC\u00f3mo le ayuda Arena\u00bb icon_color=\u00bb#00890B\u00bb open_icon_color=\u00bb#3D4647″ _builder_version=\u00bb4.27.5″ title_text_color=\u00bb#3D4647″ title_level=\u00bbh3″ 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

      \n
    • Enlaza e indexa todo el registro de productos, incluidos el DMR y el DHF, para facilitar la b\u00fasqueda<\/span><\/li>\n
    • Reduce el riesgo de infracciones, incluidas las cartas de advertencia y las observaciones del formulario 483<\/span><\/li>\n<\/ul>\n

      \n[\/et_pb_toggle][\/et_pb_column][et_pb_column type=\u00bb1_3″ _builder_version=\u00bb4.27.4″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_blurb image=\u00bbhttps:\/\/www.arenasolutions.com\/wp-content\/uploads\/Execute-Easily-1.jpg\u00bb alt=\u00bbImage-Document management concept, check electronic documents on digital documents on virtual screen\u00bb _builder_version=\u00bb4.27.5″ header_level=\u00bbh3″ 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″ body_font_size=\u00bb26px\u00bb body_line_height=\u00bb1.2em\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n

      Simplifica la validaci\u00f3n del sistema de software<\/p>\n

      \n[\/et_pb_blurb][et_pb_toggle title=\u00bbC\u00f3mo le ayuda Arena\u00bb icon_color=\u00bb#00890B\u00bb open_icon_color=\u00bb#3D4647″ _builder_version=\u00bb4.27.5″ title_text_color=\u00bb#3D4647″ title_level=\u00bbh3″ 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

        \n
      • Documenta los resultados de las pruebas de validaci\u00f3n de cada actualizaci\u00f3n del producto a todos los suscriptores<\/span><\/li>\n
      • Reduce el tiempo y los costes asociados al desarrollo y la ejecuci\u00f3n de los casos de prueba<\/span><\/li>\n<\/ul>\n

        \n[\/et_pb_toggle][\/et_pb_column][\/et_pb_row][et_pb_row module_class=\u00bblocale-hide-cn\u00bb _builder_version=\u00bb4.20.0″ custom_padding=\u00bb29px||21px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4″ _builder_version=\u00bb4.16″ global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.27.5″ text_orientation=\u00bbcenter\u00bb custom_margin=\u00bb||30px||false|false\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n

        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

        \n[\/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=\u00bb4.27.5″ _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″ admin_label=\u00bbSomalogic\u00bb _builder_version=\u00bb4.27.5″ _module_preset=\u00bb_initial\u00bb background_color=\u00bb#FFFFFF\u00bb use_background_color_gradient=\u00bbon\u00bb background_color_gradient_stops=\u00bb#ffffff 50%|#e1e2e3 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″ background_enable_image=\u00bboff\u00bb custom_margin=\u00bb0px||0px||false|false\u00bb custom_padding=\u00bb100px||0px||false|false\u00bb top_divider_style=\u00bbarrow\u00bb top_divider_color=\u00bb#e1e2e3″ bottom_divider_color=\u00bb#FFFFFF\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row column_structure=\u00bb1_2,1_2″ custom_padding_last_edited=\u00bbon|phone\u00bb _builder_version=\u00bb4.27.5″ _module_preset=\u00bb_initial\u00bb custom_margin=\u00bb0px|auto|0px|auto|false|false\u00bb custom_padding=\u00bb50px||30px||false|false\u00bb custom_padding_tablet=\u00bb50px||0px||false|false\u00bb custom_padding_phone=\u00bb0px||||false|false\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_2″ _builder_version=\u00bb4.25.1″ _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_text content_tablet=\u00bb<\/p>\n

        See How Somalogic Launches Products Faster With Arena<\/h2>\n

        SomaLogic relies on Arena PLM and QMS to meet the demands of their highly regulated environment, helping manage their digital records with robust controls. Arena’s cloud solution is essential to help SomaLogic work with geographically dispersed teams and supply chain partners.<\/span><\/span><\/p>\n

        \u00bb content_phone=\u00bb<\/p>\n

        See How Somalogic Launches Products Faster With Arena<\/h2>\n

        SomaLogic relies on Arena PLM and QMS to meet the demands of their highly regulated environment, helping manage their digital records with robust controls. Arena’s cloud solution is essential to help SomaLogic work with geographically dispersed teams and supply chain partners.<\/span><\/span><\/p>\n

        \u00bb content_last_edited=\u00bboff|desktop\u00bb disabled_on=\u00bboff|off|off\u00bb _builder_version=\u00bb4.27.5″ _module_preset=\u00bb614038c7-0a1b-43bf-9951-a4d2248c4559″ header_2_text_align=\u00bbright\u00bb header_2_font_size=\u00bb34px\u00bb header_2_letter_spacing=\u00bb1px\u00bb header_2_line_height=\u00bb1.2em\u00bb text_orientation=\u00bbright\u00bb custom_margin=\u00bb||||false|false\u00bb custom_margin_tablet=\u00bb30px||||false|false\u00bb custom_margin_phone=\u00bb30px||||false|false\u00bb custom_margin_last_edited=\u00bbon|desktop\u00bb header_2_text_align_tablet=\u00bbright\u00bb header_2_text_align_phone=\u00bbcenter\u00bb header_2_text_align_last_edited=\u00bbon|desktop\u00bb text_orientation_tablet=\u00bb\u00bb text_orientation_phone=\u00bbcenter\u00bb text_orientation_last_edited=\u00bbon|phone\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n

        Descubra c\u00f3mo Somalogic lanza sus productos m\u00e1s r\u00e1pido con Arena<\/h2>\n\n

        SomaLogic conf\u00eda en Arena PLM y QMS para cumplir las exigencias de su entorno altamente regulado, lo que le ayuda a gestionar sus registros digitales con controles s\u00f3lidos. La soluci\u00f3n en la nube de Arena es esencial para que SomaLogic pueda trabajar con equipos y socios de la cadena de suministro dispersos por distintas zonas geogr\u00e1ficas.<\/span><\/span><\/p>\n

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