{"id":26,"date":"2023-10-11T13:11:09","date_gmt":"2023-10-11T13:11:09","guid":{"rendered":"https:\/\/web.nas.dewwwe.com\/mnope\/?page_id=26"},"modified":"2025-02-25T12:49:16","modified_gmt":"2025-02-25T11:49:16","slug":"dispositifs-medicaux","status":"publish","type":"page","link":"https:\/\/mnope-management.com\/en\/dispositifs-medicaux\/","title":{"rendered":"Medical devices"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"26\" class=\"elementor elementor-26\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e9aef6f e-con-full e-flex e-con e-parent\" data-id=\"e9aef6f\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-997ec1b elementor-widget elementor-widget-heading\" data-id=\"997ec1b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Medial Devices<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7611a00 elementor-widget elementor-widget-text-editor\" data-id=\"7611a00\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>You are medical device manufacturer, subcontractor or distributor looking to turn regulatory compliance into an opportunity to improve your overall performance?<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-8feb7e7 e-flex e-con-boxed e-con e-parent\" data-id=\"8feb7e7\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5d29757 elementor-widget elementor-widget-heading\" data-id=\"5d29757\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Quality system management ISO 135485<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6031597 elementor-widget elementor-widget-text-editor\" data-id=\"6031597\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: center;\">We specialize in the management of quality systems for medical devices and can help you update your quality system in accordance with the following standards <b>ISO 13485:2016<\/b>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bfa3b80 elementor-widget elementor-widget-text-editor\" data-id=\"bfa3b80\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: center;\">We support you in setting up and maintaining your system, in collaboration with your Quality Department and all the staff concerned, to obtain or maintain your certifications, taking into account new standards and regulatory requirements.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-49314ef e-flex e-con-boxed e-con e-parent\" data-id=\"49314ef\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-af7e96d elementor-widget elementor-widget-heading\" data-id=\"af7e96d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Process approach &amp; Risk approach<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7c99273 elementor-widget elementor-widget-text-editor\" data-id=\"7c99273\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Take advantage of the transition to regulation 2017\/745 to implement or re-implement your ISO 13485 management system:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f9257d7 e-flex e-con-boxed e-con e-child\" data-id=\"f9257d7\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-7b78830 e-flex e-con-boxed e-con e-child\" data-id=\"7b78830\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b30117b elementor-widget-tablet__width-inherit elementor-widget__width-inherit elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"b30117b\" data-element_type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Development and review of process mapping<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Definition of interactions between processes with internal pilots<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Creation of process flow diagrams<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Process documentation (procedures, operating modes, forms, etc.)<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Process risk analysis<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4c9a1c0 elementor-widget-tablet__width-inherit elementor-widget__width-inherit elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"4c9a1c0\" data-element_type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Definition and writing of quality policy<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Planning and monitoring objectives, translated into action plans<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Steering the Quality management system<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Implementation of relevant performance indicators<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Development of decision-support dashboards<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-df8c83e elementor-widget-tablet__width-inherit elementor-widget__width-inherit elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"df8c83e\" data-element_type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-check\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Management of medical device dossiers in collaboration with your in-house teams and our network of dedicated experts (risk analysis, clinical evaluations, biological evaluations, IAU fitness-for-use engineering, etc.)<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Dispositifs Medicaux Vous \u00eates\u00a0fabricant,\u00a0sous-traitant\u00a0ou\u00a0distributeur\u00a0de dispositifs m\u00e9dicaux\u00a0et vous souhaitez\u00a0faire de l\u2019obligation de la conformit\u00e9\u00a0r\u00e8glementaire\u00a0une\u00a0opportunit\u00e9\u00a0d\u2019am\u00e9lioration\u00a0de votre performance globale\u00a0? Management du systeme qualit\u00e9 ISO 135485 Nous sommes sp\u00e9cialis\u00e9s dans le management des syst\u00e8mes qualit\u00e9 pour les dispositifs m\u00e9dicaux et nous vous accompagnons \u00e0 &hellip; <a class=\"kt-excerpt-readmore more-link\" href=\"https:\/\/mnope-management.com\/en\/dispositifs-medicaux\/\">Read More<\/a><\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-26","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Dispositifs M\u00e9dicaux - MNOP\u00e9 Management<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mnope-management.com\/en\/dispositifs-medicaux\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Dispositifs M\u00e9dicaux - MNOP\u00e9 Management\" \/>\n<meta property=\"og:description\" content=\"Dispositifs Medicaux Vous \u00eates\u00a0fabricant,\u00a0sous-traitant\u00a0ou\u00a0distributeur\u00a0de dispositifs m\u00e9dicaux\u00a0et vous souhaitez\u00a0faire de l\u2019obligation de la conformit\u00e9\u00a0r\u00e8glementaire\u00a0une\u00a0opportunit\u00e9\u00a0d\u2019am\u00e9lioration\u00a0de votre performance globale\u00a0? Management du systeme qualit\u00e9 ISO 135485 Nous sommes sp\u00e9cialis\u00e9s dans le management des syst\u00e8mes qualit\u00e9 pour les dispositifs m\u00e9dicaux et nous vous accompagnons \u00e0 &hellip; Read More\" \/>\n<meta property=\"og:url\" content=\"https:\/\/mnope-management.com\/en\/dispositifs-medicaux\/\" \/>\n<meta property=\"og:site_name\" content=\"MNOP\u00e9 Management\" \/>\n<meta property=\"article:modified_time\" content=\"2025-02-25T11:49:16+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/mnope-management.com\/dispositifs-medicaux\/\",\"url\":\"https:\/\/mnope-management.com\/dispositifs-medicaux\/\",\"name\":\"Dispositifs M\u00e9dicaux - MNOP\u00e9 Management\",\"isPartOf\":{\"@id\":\"https:\/\/mnope-management.com\/#website\"},\"datePublished\":\"2023-10-11T13:11:09+00:00\",\"dateModified\":\"2025-02-25T11:49:16+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/mnope-management.com\/dispositifs-medicaux\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/mnope-management.com\/dispositifs-medicaux\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/mnope-management.com\/dispositifs-medicaux\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/mnope-management.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Dispositifs M\u00e9dicaux\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/mnope-management.com\/#website\",\"url\":\"https:\/\/mnope-management.com\/\",\"name\":\"MNOP\u00e9 Management\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\/\/mnope-management.com\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/mnope-management.com\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/mnope-management.com\/#organization\",\"name\":\"MNOP\u00e9 Management\",\"url\":\"https:\/\/mnope-management.com\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/mnope-management.com\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/mnope-management.com\/wp-content\/uploads\/2023\/10\/cropped-Logo.png\",\"contentUrl\":\"https:\/\/mnope-management.com\/wp-content\/uploads\/2023\/10\/cropped-Logo.png\",\"width\":351,\"height\":64,\"caption\":\"MNOP\u00e9 Management\"},\"image\":{\"@id\":\"https:\/\/mnope-management.com\/#\/schema\/logo\/image\/\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Dispositifs M\u00e9dicaux - MNOP\u00e9 Management","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/mnope-management.com\/en\/dispositifs-medicaux\/","og_locale":"en_US","og_type":"article","og_title":"Dispositifs M\u00e9dicaux - MNOP\u00e9 Management","og_description":"Dispositifs Medicaux Vous \u00eates\u00a0fabricant,\u00a0sous-traitant\u00a0ou\u00a0distributeur\u00a0de dispositifs m\u00e9dicaux\u00a0et vous souhaitez\u00a0faire de l\u2019obligation de la conformit\u00e9\u00a0r\u00e8glementaire\u00a0une\u00a0opportunit\u00e9\u00a0d\u2019am\u00e9lioration\u00a0de votre performance globale\u00a0? 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