{"id":6919,"date":"2016-07-15T14:19:28","date_gmt":"2016-07-15T12:19:28","guid":{"rendered":"https:\/\/productosanitario.es\/medical-device-technical-manager\/"},"modified":"2025-03-06T15:45:52","modified_gmt":"2025-03-06T14:45:52","slug":"medical-device-technical-manager","status":"publish","type":"page","link":"https:\/\/productosanitario.es\/en\/medical-device-technical-manager\/","title":{"rendered":"Medical Device Technical Manager"},"content":{"rendered":"\t\t
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Technical Manager OF MEDICAL DEVICES<\/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
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This is the qualified person who will supervise the medical device manufactured, imported or distributed by the company. The figure of the technical manager is a requirement imposed by Spanish legislation on medical devices.<\/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

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Royal Decree 192\/2023<\/strong><\/a> establishes that every medical device manufacturing company will have a university graduate, with appropriate training and experience in relation to the product in their charge, who will exercise direct supervision of the activities carried out by the company for the manufacture of the medical device.<\/p>

The activities carried out by the company will be understood as the manufacture of the product, together with all the processes related to it, all of them complying with the regulatory requirements applicable<\/a> to both the company and the product<\/a>.<\/p>

The relationship between the company and the technician in charge<\/a> will be documented by drawing up, and signing, a contract that specifies the time dedication of the person holding the position to the company with which he or she collaborates, as well as the tasks for which he or she is responsible as the technical manager<\/a> of the company.<\/p>

As part of the aforementioned tasks or responsibilities, it may be that of acting as a contact person for the surveillance system<\/a>, by which the product is monitored, after it is placed on the market, in order to collect, analyze and control the data obtained and carry out notification activities to Authorities and Users. in case of incident, or any other that may be required.<\/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

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Distribution<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Distribution and sales activities will also require the supervision of a technical manager to ensure 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

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Import<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The activity of importing medical devices, as a requirement of the prior licence that must be requested, will also be obliged to have a technical manager.<\/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

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At PS Consulting<\/b> we have a technical manager service for companies in the medical device sector, if you require it, do not hesitate to 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

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Blog<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Technical Manager OF MEDICAL DEVICES This is the qualified person who will supervise the medical device manufactured, imported or distributed by the company. The figure of the technical manager is a requirement imposed by Spanish legislation on medical devices. Royal Decree 192\/2023 establishes that every medical device manufacturing company will have a university graduate, with […]<\/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-6919","page","type-page","status-publish","hentry"],"yoast_head":"\nMedical Device Technical Manager - Consultor\u00eda de producto sanitario<\/title>\n<meta name=\"description\" content=\"Technical manager of medical devices is the person in charge of guaranteeing and maintaining the quality of the product under the applicable regulation\" \/>\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\/\" \/>\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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