{"id":6891,"date":"2019-02-09T11:42:42","date_gmt":"2019-02-09T10:42:42","guid":{"rendered":"https:\/\/productosanitario.es\/risk-management\/"},"modified":"2025-03-06T15:38:08","modified_gmt":"2025-03-06T14:38:08","slug":"risk-management","status":"publish","type":"page","link":"https:\/\/productosanitario.es\/en\/risk-management\/","title":{"rendered":"Risk Management"},"content":{"rendered":"\t\t
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Risk Management<\/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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A continuous process throughout the life cycle of the manufactured device that detects, identifies, analyzes, and manages the foreseeable risks of the manufactured medical device.<\/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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The documentation, implementation and maintenance of a product risk management system<\/strong><\/a> is one of the obligations for medical device manufacturers<\/strong>.<\/p>

This system’s mission is to identify, analyse and manage the foreseeable risks of any medical device<\/a><\/strong> in relation to its safety and operational requirements.<\/p>

The system aims to mitigate as much as possible, even eliminate the possible risks<\/strong> associated with the product, as well as reduce as much as possible the residuals that cannot be eliminated in their entirety.<\/p>

The manufacturer shall establish a risk-benefit<\/strong><\/a> analysis of the device and, with this, a risk acceptance criterion that allows certain risks to be assumed in relation to the benefit provided by the medical device.<\/p>

Cooperation in mitigating the risks<\/strong> represented by medical devices<\/strong> already placed on the market corresponds to all the economic agents involved in the distribution and sale of the product, proportional to their degree of relationship with the risk encountered, but it is important to consider that all actors have involvement and obligations.<\/p>

The risks inherent in each type of device, together with other parameters, derive the classification of medical devices<\/strong><\/a>, from which the main requirements applicable to the medical device are extracted.<\/p>

It is, for all of the above, an iterative and constant process throughout the product’s life cycle, and must be documented<\/strong> and maintained throughout this time.<\/p>

It will always be a planned process that must be documented in a specific risk management<\/a> plan<\/strong>, then documented in the consequent risk file(s).<\/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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Risk Management System<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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All the actions of the risk management system will respond to the principle of safety integration, and must therefore take into account the state of science, the analysis of the benefit associated with the product and the information to the user or patient of possible residual risks.<\/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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Contact us for any questions or queries regarding risk management and we will advise you in the best possible way.<\/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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Risk Management A continuous process throughout the life cycle of the manufactured device that detects, identifies, analyzes, and manages the foreseeable risks of the manufactured medical device. The documentation, implementation and maintenance of a product risk management system is one of the obligations for medical device manufacturers. This system’s mission is to identify, analyse and […]<\/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-6891","page","type-page","status-publish","hentry"],"yoast_head":"\nRisk Management - Consultor\u00eda de producto sanitario<\/title>\n<meta name=\"description\" content=\"Risk management in medical devices corresponds to the systematic management to detect possible hazards and mitigate their risks\" \/>\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\/risk-management\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Risk Management - Consultor\u00eda de producto sanitario\" \/>\n<meta property=\"og:description\" content=\"Risk management in medical devices corresponds to the systematic management to detect possible hazards and mitigate their risks\" \/>\n<meta property=\"og:url\" content=\"https:\/\/productosanitario.es\/en\/risk-management\/\" \/>\n<meta property=\"og:site_name\" content=\"Consultor\u00eda de producto sanitario\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/fernando.atienza.5667\" \/>\n<meta property=\"article:modified_time\" content=\"2025-03-06T14:38:08+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:\/\/productosanitario.es\/en\/risk-management\/\",\"url\":\"https:\/\/productosanitario.es\/en\/risk-management\/\",\"name\":\"Risk Management - 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