{"id":6881,"date":"2019-02-09T11:04:44","date_gmt":"2019-02-09T10:04:44","guid":{"rendered":"https:\/\/productosanitario.es\/technical-documentation\/"},"modified":"2025-03-07T17:37:19","modified_gmt":"2025-03-07T16:37:19","slug":"technical-documentation","status":"publish","type":"page","link":"https:\/\/productosanitario.es\/en\/technical-documentation\/","title":{"rendered":"Technical documentation"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"6881\" class=\"elementor elementor-6881 elementor-2365\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e83f325 e-flex e-con-boxed e-con e-parent\" data-id=\"e83f325\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0210224 elementor-widget__width-initial elementor-widget-mobile__width-inherit elementor-widget elementor-widget-heading\" data-id=\"0210224\" data-element_type=\"widget\" data-e-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\"><b>Medical Device<\/b> Technical Documentation<\/h1>\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-8a8589a e-flex e-con-boxed e-con e-parent\" data-id=\"8a8589a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d1feb00 elementor-widget__width-inherit elementor-widget-tablet__width-inherit elementor-widget elementor-widget-heading\" data-id=\"d1feb00\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">We understand technical documentation as the document or its set that develops the properties, characteristics and design and development process in relation to the medical device manufactured by the company.<\/p>\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-229674c e-con-full e-flex e-con e-parent\" data-id=\"229674c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-cc8234f e-con-full e-flex e-con e-child\" data-id=\"cc8234f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-eeefcc0 elementor-widget elementor-widget-text-editor\" data-id=\"eeefcc0\" data-element_type=\"widget\" data-e-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>The <strong>technical documentation of the <a href=\"https:\/\/productosanitario.es\/category\/producto-sanitario\/\" target=\"_blank\" rel=\"noopener\">medical device<\/a><\/strong> must be prepared by the manufacturer. It will be clear, unambiguous and orderly, while also being easy to search for and retrieve.<\/p><p>You will have a description of the product, with its specifications and the patients or users to whom it is addressed, including its variants and complements.<\/p><p>It will always refer to previous generations of product, if any, and will contain the product information that the manufacturer must provide with it.<\/p><p>The <strong>product documentation<\/strong> shall also contain the information, and history, of the design and development of the product, its technical specifications and the exact identification of the sites and suppliers and\/or subcontractors involved in the life cycle of the product.<\/p><p>The technical product documentation shall also contain the requirements applicable to the product, as well as the justification for their compliance.<\/p><p>It will also contain the necessary documents that provide the risk <a href=\"https:\/\/productosanitario.es\/category\/gestion-de-riesgos-producto-sanitario\/\" target=\"_blank\" rel=\"noopener\"><strong>management<\/strong> <\/a>of the product, including the risk\/benefit analysis of the same.<\/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-fee7d1b e-con-full e-flex e-con e-child\" data-id=\"fee7d1b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6f41e32 e-flex e-con-boxed e-con e-parent\" data-id=\"6f41e32\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-64a4989 e-con-full e-flex e-con e-child\" data-id=\"64a4989\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-032adbb elementor-widget elementor-widget-heading\" data-id=\"032adbb\" data-element_type=\"widget\" data-e-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\">Clinical evaluation of the product<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8c7b63d elementor-widget elementor-widget-text-editor\" data-id=\"8c7b63d\" data-element_type=\"widget\" data-e-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>The technical documentation will also include the clinical evaluation of the product, as well as the clinical data that support it, as well as the verification and validation of the product.<\/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-4fb1e78 e-con-full e-flex e-con e-child\" data-id=\"4fb1e78\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d1133a2 elementor-widget elementor-widget-heading\" data-id=\"d1133a2\" data-element_type=\"widget\" data-e-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\">Additional documentation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8234823 elementor-widget elementor-widget-text-editor\" data-id=\"8234823\" data-element_type=\"widget\" data-e-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>In addition, it shall include all additional documentation required to document full compliance with the applicable requirements.<\/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\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f5d76c3 e-flex e-con-boxed e-con e-parent\" data-id=\"f5d76c3\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6e643bc elementor-widget__width-initial elementor-widget-tablet__width-inherit elementor-widget elementor-widget-heading\" data-id=\"6e643bc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">At <b>PS Consulting<\/b> we have specialized in medical device documentation requirements, please contact us.<\/p>\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-5c7c067 e-flex e-con-boxed e-con e-parent\" data-id=\"5c7c067\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a5b3023 elementor-widget elementor-widget-heading\" data-id=\"a5b3023\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Blog<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-23a117b elementor-grid-tablet-3 elementor-widget__width-inherit elementor-grid-3 elementor-grid-mobile-1 elementor-widget elementor-widget-loop-grid\" data-id=\"23a117b\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;template_id&quot;:6945,&quot;columns_tablet&quot;:3,&quot;row_gap_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:20,&quot;sizes&quot;:[]},&quot;_skin&quot;:&quot;post&quot;,&quot;columns&quot;:&quot;3&quot;,&quot;columns_mobile&quot;:&quot;1&quot;,&quot;edit_handle_selector&quot;:&quot;[data-elementor-type=\\&quot;loop-item\\&quot;]&quot;,&quot;row_gap&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;row_gap_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"loop-grid.post\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-loop-nothing-found-message\">\n\t\t<\/div>\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>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Medical Device Technical Documentation We understand technical documentation as the document or its set that develops the properties, characteristics and design and development process in relation to the medical device manufactured by the company. The technical documentation of the medical device must be prepared by the manufacturer. It will be clear, unambiguous and orderly, while [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-6881","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Technical documentation - Consultor\u00eda de producto sanitario<\/title>\n<meta name=\"description\" content=\"Technical documentation is the set of medical device documents that contain the requirements applicable to the device\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/productosanitario.es\/en\/technical-documentation\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Technical documentation - 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