{"id":6943,"date":"2018-12-13T20:12:17","date_gmt":"2018-12-13T20:12:17","guid":{"rendered":"https:\/\/avna.com\/quality\/compliance-processes\/"},"modified":"2025-05-05T14:42:10","modified_gmt":"2025-05-05T18:42:10","slug":"compliance-processes","status":"publish","type":"page","link":"https:\/\/avna.com\/es\/quality\/compliance-processes\/","title":{"rendered":"Cumplimiento &#038; Procesos"},"content":{"rendered":"\n\n<section class=\"header-block\"><figure class=\"bg\" style=\"background-image: url(https:\/\/avna.com\/wp-content\/uploads\/2018\/12\/Blue-Background-Treatment8.jpg); \"><\/figure><div class=\"section-wrapper\"><div class=\"text-wrapper\"><div class=\"text-background\"><\/div><div class=\"header-image lock-to-right \" style=\"background-image: url(https:\/\/avna.com\/wp-content\/uploads\/2023\/12\/avna-compliance.png);\"><\/div><div class=\"header-text\"><h1>Validaci\u00f3n en cada paso<\/h1>\n<h2>Cumplimiento y procesos<\/h2>\n<p><strong>Todos los d\u00edas trabajamos para superar las expectativas del cliente en cuanto a procesos, calidad y cumplimiento, porque las vidas dependen de ello.<\/strong><\/p>\n<p>Con tres ubicaciones y los especialistas l\u00edderes de la industria en ingenier\u00eda, fabricaci\u00f3n de herramientas y producci\u00f3n, AVNA es reconocida por la fabricaci\u00f3n de calidad para aplicaciones m\u00e9dicas. Ofrecemos 20996m2 dedicados a la excelencia del proceso para cumplir con los rigurosos requerimientos de la industria de dispositivos m\u00e9dicos y colaboraremos con usted a lo largo del ciclo de vida del proyecto para garantizar un alto nivel de calidad que resulte en tranquilidad para sus clientes.<\/p>\n<\/div><\/div><\/div><\/section>\n\n\n<section class=\"wp-block-smart-section-section white-background\"><div class=\"section-wrapper\">\n<h2 class=\"has-text-align-center wp-block-heading\" id=\"mce_19\">Excelencia orientada a resultados, personalizada para su proyecto.<\/h2>\n\n\n\n<p>AVNA  ha desarrollado un estricto proceso de validaci\u00f3n interno que mantiene la calidad y la consistencia incluso para los pedidos m\u00e1s complejos. Dise\u00f1amos y construimos soluciones personalizadas basadas en los requisitos del pedido, incluyendo tecnolog\u00edas para la <a href=\"https:\/\/avna.com\/es\/design-support-and-development\/design-for-automation\/\">automatizaci\u00f3n<\/a> de la producci\u00f3n y <a href=\"https:\/\/avna.com\/es\/capabilities\/assemblies\/\">ensamblaje<\/a>, y podemos garantizar el cumplimiento de los requerimientos de la industria incluso en los proyectos m\u00e1s precisos y exigentes.<\/p>\n<\/div><\/section>\n\n\n\n<section class=\"wp-block-smart-section-section\"><div class=\"section-wrapper\">\n<div class=\"wp-block-columns has-2-columns okay-2col-table is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column okay-2col-left is-layout-flow wp-block-column-is-layout-flow\">\n<p>Nuestra mzanufactura de precisi\u00f3n para aplicaciones m\u00e9dicas est\u00e1 dise\u00f1ada para la calidad: identificamos y verificamos la efectividad de las variables cr\u00edticas del proceso a lo largo del dise\u00f1o, la producci\u00f3n y el ensamblaje, con esfuerzos que incluyen:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Dibujos\nCAD: incluidos esquemas el\u00e9ctricos, cuando sea necesario<\/li>\n\n\n\n<li>Experimentos\ny resultados dise\u00f1ados<\/li>\n\n\n\n<li>Documentaci\u00f3n\nde seguridad<\/li>\n\n\n\n<li>Definiciones\nde proceso a cada\npaso para describir claramente las expectativas y los est\u00e1ndares, incluyendo entradas y\nsalidas<\/li>\n\n\n\n<li>Instrucciones\nde instalaci\u00f3n y documentaci\u00f3n de Listas de repuestos<\/li>\n\n\n\n<li>Instrucciones\nde trabajo<\/li>\n\n\n\n<li>Documentaci\u00f3n\nde calidad,\nplanes de control de productos y PFMEA<\/li>\n\n\n\n<li>Mantenimiento\npreventivo<\/li>\n\n\n\n<li>Listas\nde repuestos<\/li>\n<\/ul>\n\n\n\n<p>Nuestras operaciones centradas en el cliente est\u00e1n impulsadas por la calidad, y con m\u00e1s de un siglo de experiencia, AVNA est\u00e1 listo para ayudarlo a mejorar sus resultados. Al trabajar en la manufactura de aplicaciones de dispositivos m\u00e9dicos, los proyectos suelen seguir un proceso est\u00e1ndar:<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column okay-2col-right is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image\"><img decoding=\"async\" width=\"818\" height=\"425\" src=\"https:\/\/avna.com\/wp-content\/uploads\/2019\/01\/quality_callout_images_818x425px.jpg\" alt=\"\" class=\"wp-image-2598\" srcset=\"https:\/\/avna.com\/wp-content\/uploads\/2019\/01\/quality_callout_images_818x425px.jpg 818w, https:\/\/avna.com\/wp-content\/uploads\/2019\/01\/quality_callout_images_818x425px-300x156.jpg 300w, https:\/\/avna.com\/wp-content\/uploads\/2019\/01\/quality_callout_images_818x425px-768x399.jpg 768w, https:\/\/avna.com\/wp-content\/uploads\/2019\/01\/quality_callout_images_818x425px-100x52.jpg 100w, https:\/\/avna.com\/wp-content\/uploads\/2019\/01\/quality_callout_images_818x425px-200x104.jpg 200w, https:\/\/avna.com\/wp-content\/uploads\/2019\/01\/quality_callout_images_818x425px-400x208.jpg 400w, https:\/\/avna.com\/wp-content\/uploads\/2019\/01\/quality_callout_images_818x425px-600x312.jpg 600w, https:\/\/avna.com\/wp-content\/uploads\/2019\/01\/quality_callout_images_818x425px-800x416.jpg 800w\" sizes=\"(max-width: 818px) 100vw, 818px\" \/><\/figure>\n\n\n\n<section class=\"wp-block-smart-section-section blue-certs\"><div class=\"section-wrapper\">\n<h4 class=\"wp-block-heading\" id=\"mce_20\">Nuestras certificaciones y registros de fabricaci\u00f3n de dispositivos m\u00e9dicos incluyen:<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/avna.com\/wp-content\/uploads\/2024\/10\/AVNA-FM-597099-Exp-10-2-2027.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Operaciones en los Estados Unidos: ISO 13485: 2016<\/a><a href=\"https:\/\/avna.com\/wp-content\/uploads\/2024\/10\/FM-597099-Exp-10-2-2027.pdf\" target=\"_blank\" rel=\"noreferrer noopener\"> <\/a>(ver PDF)<\/li>\n\n\n\n<li><a href=\"https:\/\/avna.com\/wp-content\/uploads\/2025\/05\/ISO13485-Certificate-AVNA-Costa-Rica-2025.pdf\">Operaciones en Costa Rica: ISO 13485: 2016<\/a> (ver PDF)<\/li>\n<\/ul>\n<\/div><\/section>\n<\/div>\n<\/div>\n\n\n\n<figure class=\"wp-block-gallery has-nested-images columns-6 wp-block-gallery-1 is-layout-flex wp-block-gallery-is-layout-flex\">\n<figure class=\"wp-block-image\"><img decoding=\"async\" width=\"300\" height=\"225\" data-id=\"6953\" src=\"https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-01-1-ES.png\" alt=\"\" class=\"wp-image-6953\" srcset=\"https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-01-1-ES.png 300w, https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-01-1-ES-100x75.png 100w, https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-01-1-ES-200x150.png 200w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" width=\"300\" height=\"225\" data-id=\"6963\" src=\"https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-02-1-ES.png\" alt=\"\" class=\"wp-image-6963\" srcset=\"https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-02-1-ES.png 300w, https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-02-1-ES-100x75.png 100w, https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-02-1-ES-200x150.png 200w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" width=\"300\" height=\"225\" data-id=\"6961\" src=\"https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-03-1-ES.png\" alt=\"\" class=\"wp-image-6961\" srcset=\"https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-03-1-ES.png 300w, https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-03-1-ES-100x75.png 100w, https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-03-1-ES-200x150.png 200w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" width=\"300\" height=\"225\" data-id=\"6959\" src=\"https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-04-1-ES.png\" alt=\"\" class=\"wp-image-6959\" srcset=\"https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-04-1-ES.png 300w, https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-04-1-ES-100x75.png 100w, https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-04-1-ES-200x150.png 200w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" width=\"300\" height=\"225\" data-id=\"6957\" src=\"https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-05-1-ES.png\" alt=\"\" class=\"wp-image-6957\" srcset=\"https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-05-1-ES.png 300w, https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-05-1-ES-100x75.png 100w, https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-05-1-ES-200x150.png 200w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" width=\"300\" height=\"225\" data-id=\"6955\" src=\"https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-06-2-ES.png\" alt=\"\" class=\"wp-image-6955\" srcset=\"https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-06-2-ES.png 300w, https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-06-2-ES-100x75.png 100w, https:\/\/avna.com\/wp-content\/uploads\/2020\/04\/process-graphic-update-06-2-ES-200x150.png 200w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/figure>\n<\/figure>\n\n\n\n<div class=\"wp-block-media-text alignwide has-media-on-the-right is-stacked-on-mobile callout-image cta-it\" style=\"grid-template-columns:auto 49%\"><div class=\"wp-block-media-text__content\">\n<h3 class=\"wp-block-heading\"><em>Part&nbsp;of&nbsp;Something&nbsp;Greater. <\/em>Comprobado en cada paso.<\/h3>\n\n\n\n<p class=\"has-regular-font-size\">Con la validaci\u00f3n de cada etapa del proceso de producci\u00f3n, incluyendo las verificaciones de cumplimiento para los requisitos de instalaci\u00f3n, operaci\u00f3n y rendimiento, AVNA  trabaja para superar las expectativas del cliente. Nuestros procesos de manufactura de aplicaciones m\u00e9dicas se adhiere a la norma <a href=\"https:\/\/avna.com\/wp-content\/uploads\/2022\/07\/CR-ISO-13485-exp-7-25.pdf\">ISO13485: 2016<\/a> Sistema de gesti\u00f3n de calidad. Estamos listos y felices de revisar las necesidades de su proyecto y desarrollar una soluci\u00f3n personalizada para su aplicaci\u00f3n.<\/p>\n\n\n\n<p><a href=\"https:\/\/avna.com\/es\/contact-us\/\">Cont\u00e1ctenos<\/a> o programe una cita en nuestros <a href=\"https:\/\/avna.com\/es\/design-support-and-development\/nextech-labs\/\">Laboratorios NexTech<\/a> y descubra c\u00f3mo nuestra colaboraci\u00f3n centrada en el cliente mejorar\u00e1 los resultados en su pr\u00f3ximo proyecto.<\/p>\n<\/div><figure class=\"wp-block-media-text__media\"><img decoding=\"async\" width=\"800\" height=\"659\" src=\"https:\/\/avna.com\/wp-content\/uploads\/2019\/09\/New-CTA-Box800x659.jpg\" alt=\"\" class=\"wp-image-5422 size-full\" srcset=\"https:\/\/avna.com\/wp-content\/uploads\/2019\/09\/New-CTA-Box800x659.jpg 800w, https:\/\/avna.com\/wp-content\/uploads\/2019\/09\/New-CTA-Box800x659-300x247.jpg 300w, https:\/\/avna.com\/wp-content\/uploads\/2019\/09\/New-CTA-Box800x659-768x633.jpg 768w, https:\/\/avna.com\/wp-content\/uploads\/2019\/09\/New-CTA-Box800x659-100x82.jpg 100w, https:\/\/avna.com\/wp-content\/uploads\/2019\/09\/New-CTA-Box800x659-200x165.jpg 200w, https:\/\/avna.com\/wp-content\/uploads\/2019\/09\/New-CTA-Box800x659-400x330.jpg 400w, https:\/\/avna.com\/wp-content\/uploads\/2019\/09\/New-CTA-Box800x659-600x494.jpg 600w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/figure><\/div>\n<\/div><\/section>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":6694,"parent":6931,"menu_order":17,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_yoast_wpseo_title":"Cumplimiento en la manufactura de Aplicaciones M\u00e9dicas | %%sitename%%","_yoast_wpseo_metadesc":"Excelencia basada en resultados personalizada para su proyecto: conozca los procesos de AVNA y el cunplimiento de los requerimientos en la manufactura de aplicaciones m\u00e9dicas.","_metasync_otto_title":"","_metasync_otto_description":"","rank_math_title":"","rank_math_description":"","footnotes":""},"class_list":["post-6943","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.12 (Yoast SEO v25.4) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Cumplimiento en la manufactura de Aplicaciones M\u00e9dicas | AVNA<\/title>\n<meta name=\"description\" content=\"Excelencia basada en resultados personalizada para su proyecto: conozca los procesos de AVNA y el cunplimiento de los requerimientos en la manufactura de aplicaciones m\u00e9dicas.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/avna.com\/es\/quality\/compliance-processes\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cumplimiento &amp; 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