{"id":6921,"date":"2019-02-27T11:34:03","date_gmt":"2019-02-27T10:34:03","guid":{"rendered":"https:\/\/productosanitario.es\/medical-device-technical-manager-2\/"},"modified":"2025-03-06T15:46:21","modified_gmt":"2025-03-06T14:46:21","slug":"medical-device-technical-manager-2","status":"publish","type":"page","link":"https:\/\/productosanitario.es\/en\/medical-device-technical-manager-2\/","title":{"rendered":"Medical Device Technical Manager"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"6921\" class=\"elementor elementor-6921 elementor-2758\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-122cb7a e-con-full e-flex e-con e-parent\" data-id=\"122cb7a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-90b032d e-con-full e-flex e-con e-child\" data-id=\"90b032d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-46bb162 elementor-widget elementor-widget-heading\" data-id=\"46bb162\" 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 Manager<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-92de629 elementor-widget elementor-widget-text-editor\" data-id=\"92de629\" 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 figure of <a href=\"https:\/\/productosanitario.es\/en\/medical-device-technical-manager\/\" target=\"_blank\" rel=\"noopener\">technical manager<\/a> is a requirement established by current regulations. The company will certify the availability of a <a href=\"https:\/\/productosanitario.es\/en\/medical-device-technical-manager\/\" target=\"_blank\" rel=\"noopener\">technical manager<\/a> by means of a contract established between both parties. <\/p><p>It must have qualifications appropriate to the products it monitors. The suitability of the qualification will be assessed, and confirmed, by the <a href=\"https:\/\/www.productosanitario.es\/aemps\" target=\"_blank\" rel=\"noopener\">Spanish Agency for Medicines and Medical Devices<\/a>, in its capacity as the competent authority in Spain. <\/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-834d0c0 e-con-full e-flex e-con e-child\" data-id=\"834d0c0\" 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-293a21a e-flex e-con-boxed e-con e-parent\" data-id=\"293a21a\" 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-5b0c49a e-con-full e-flex e-con e-child\" data-id=\"5b0c49a\" 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<div class=\"elementor-element elementor-element-ba7a6f9 e-con-full e-flex e-con e-child\" data-id=\"ba7a6f9\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1d4f1f8 elementor-widget elementor-widget-text-editor\" data-id=\"1d4f1f8\" 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 the case of mass production, grouping, sterilization and importation, the <a href=\"https:\/\/productosanitario.es\/en\/medical-device-technical-manager\/\" target=\"_blank\" rel=\"noopener\">Technical Manager<\/a> must necessarily have a university degree in relation to the products manufactured, regardless of whether they are serial or custom-made products.<\/p><p>The technical manager may hold the position in more than one company, provided that the volume of manufacture, the time spent in each of them and the distance that separates them allows them to carry out all their responsibilities.<\/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-9a1b937 e-flex e-con-boxed e-con e-parent\" data-id=\"9a1b937\" 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-d113719 elementor-widget elementor-widget-text-editor\" data-id=\"d113719\" 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 responsibilities of the <a href=\"https:\/\/productosanitario.es\/en\/medical-device-technical-manager\/\" target=\"_blank\" rel=\"noopener\">Technical Manager<\/a> are as follows:<\/p><ul><li>Supervise the company&#8217;s activities in relation to the medical device.<\/li><li>Check that the medical devices manufactured, imported, grouped and\/or sterilized comply with the applicable regulatory requirements.<\/li><li>Guarantee the suitability of the <a href=\"https:\/\/www.productosanitario.es\/expediente-tecnico-del-producto-sanitario\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">technical file<\/a>, as well as any other document required by regulation, in accordance with the company&#8217;s activity in relation to the medical device (manufacture, grouping, import or sterilisation.<\/li><li>Review, direct and manage possible incidents involving the medical device, in accordance with the <a href=\"https:\/\/www.productosanitario.es\/sistema-de-vigilancia\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">surveillance system<\/a>.<\/li><li>Supervision, registration and adaptation of the implementation cards to those products that are applicable to them.<\/li><li>Collaborate, and act as their interlocutor, with the health authorities in cases where appropriate.<\/li><li>Provide the health authorities with documentation demonstrating the conformity of the product whenever required by them.<\/li><li>Preparation, management and supervision of marketing <a href=\"https:\/\/productosanitario.es\/en\/placing-on-the-market-communication\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">or marketing<\/a> communications of the products to which it is applicable.<\/li><li>Preparation and supervision of the documentation required in the register of those responsible for placing on the market the placing on the market of the products that are applicable.<\/li><li>Coordination and presentation of the authorisation of trials or clinical research.<\/li><li>Control and authorisation of advertising and marketing content related to the product, always within the law.<\/li><li>For manufacturing companies, compliance with regulatory <a href=\"https:\/\/productosanitario.es\/en\/medical-device-requirements\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">requirements <\/a>and the performance and documentation of the tests that are applicable to the company&#8217;s <a href=\"https:\/\/www.productosanitario.es\/producto-sanitario\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">medical device<\/a> .<\/li><li>For grouping companies, ensure that all the products that make up the grouping have CE marking. Ensure that all products will be used in accordance with the <a href=\"https:\/\/www.productosanitario.es\/finalidad-prevista\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">intended purpose<\/a> specified by their respective manufacturer. Guarantee that the product resulting from the grouping, through its documentation, includes the information provided by each of the respective manufacturers. That prior to its placing on the market, the legislative obligations regarding <a href=\"https:\/\/productosanitario.es\/en\/placing-on-the-market-communication\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">the communication of placing on the market<\/a> have been complied with.   <\/li><li>In the case of sterilizing companies, that the procedures have been validated, with positive results, that before releasing each batch or product, the requirements applied are in accordance with the applicable requirements.<\/li><li>In the case of importing companies, that the product has the declarations, certifications and any document that is required in relation to its nature. The edition of the required documentation, in accordance with the applicable needs. Certify that all warnings, advice and recommendations applicable to the country where the product is to be distributed have been included.  <\/li><\/ul>\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-a7b581e e-flex e-con-boxed e-con e-parent\" data-id=\"a7b581e\" 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-1b8c52c elementor-widget elementor-widget-heading\" data-id=\"1b8c52c\" 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-8fbfc46 elementor-grid-tablet-3 elementor-widget__width-inherit elementor-grid-3 elementor-grid-mobile-1 elementor-widget elementor-widget-loop-grid\" data-id=\"8fbfc46\" 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<div class=\"elementor-element elementor-element-668f904 e-flex e-con-boxed e-con e-parent\" data-id=\"668f904\" 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-408cf62 elementor-widget elementor-widget-shortcode\" data-id=\"408cf62\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-shortcode\">\t\t<div data-elementor-type=\"section\" data-elementor-id=\"6931\" class=\"elementor elementor-6931 elementor-5834 elementor-5834\" data-elementor-post-type=\"elementor_library\">\n\t\t\t<div class=\"elementor-element elementor-element-182f940 e-con-full e-flex e-con e-parent\" data-id=\"182f940\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-960a9a6 e-con-full e-flex e-con e-child\" data-id=\"960a9a6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a65ff32 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"a65ff32\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-phone-alt\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M497.39 361.8l-112-48a24 24 0 0 0-28 6.9l-49.6 60.6A370.66 370.66 0 0 1 130.6 204.11l60.6-49.6a23.94 23.94 0 0 0 6.9-28l-48-112A24.16 24.16 0 0 0 122.6.61l-104 24A24 24 0 0 0 0 48c0 256.5 207.9 464 464 464a24 24 0 0 0 23.4-18.6l24-104a24.29 24.29 0 0 0-14.01-27.6z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\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-cf19537 elementor-widget elementor-widget-heading\" data-id=\"cf19537\" 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\">Contact<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c0174c9 elementor-widget-mobile__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"c0174c9\" 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>Write to us at<br><a href=\"mailto:info@productosanitario.es\"><span style=\"text-decoration: underline; color: #ffffff;\">info@productosanitario.es<\/span><\/a> <br>voice call or Whatsapp<br><span style=\"color: #ffffff;\">+34 669 27 21 63<\/span><\/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-bb888e6 e-con-full e-flex e-con e-child\" data-id=\"bb888e6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b86b8c1 elementor-widget elementor-widget-heading\" data-id=\"b86b8c1\" 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\">or fill out our form.<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-17df433 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"17df433\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/productosanitario.es\/en\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Form<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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<\/div>\n\t\t\t\t<\/div>\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 Manager The figure of technical manager is a requirement established by current regulations. The company will certify the availability of a technical manager by means of a contract established between both parties. It must have qualifications appropriate to the products it monitors. The suitability of the qualification will be assessed, and confirmed, [&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-6921","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>Medical Device Technical Manager - Consultor\u00eda de producto sanitario<\/title>\n<meta name=\"description\" content=\"The technician responsible for medical devices is the figure required by the Spanish National Authority to ensure compliance with requirements\" \/>\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\/medical-device-technical-manager-2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Device Technical Manager - 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