{"id":6883,"date":"2019-02-09T11:17:56","date_gmt":"2019-02-09T10:17:56","guid":{"rendered":"https:\/\/productosanitario.es\/clinical-evaluation-of-medical-devices\/"},"modified":"2025-03-07T17:38:12","modified_gmt":"2025-03-07T16:38:12","slug":"clinical-evaluation-of-medical-devices","status":"publish","type":"page","link":"https:\/\/productosanitario.es\/en\/clinical-evaluation-of-medical-devices\/","title":{"rendered":"Clinical evaluation of medical devices"},"content":{"rendered":"\t\t
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Clinical evaluation<\/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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Systematic, planned and documented process by which the clinical data of the medical device is collected, analyzed and evaluated to verify its safety and operation.<\/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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Clinical evaluation<\/strong><\/a> is an iterative, systematic, planned, documented and continuous process of evaluating data and information that allows the manufacturer, through its analysis and evaluation, to guarantee the clinical safety of the medical device<\/strong><\/a>.<\/p>\n

The clinical evaluation<\/strong> will be thorough and objective, taking into account both favorable and unfavorable data.<\/p>\n

Their scope, depth and breadth shall be proportionate to the nature, classification, intended purpose and foreseeable risks of each product<\/strong>.<\/p>\n

The assessment may be based on clinical data<\/a> of devices<\/strong> from which sound conclusions can be drawn due to their similarity and equivalence, as well as on clinical research<\/strong><\/a> carried out in order to verify product conformity.<\/p>\n

In the analysis of equivalent products<\/strong> , the technical, biological and clinical characteristics of the devices will be taken into account, to the extent that the differences do not imply clinical differences regarding their clinical safety and <\/b>performance of the product<\/strong>, always basing the equivalences on scientific data justified by the manufacturer.<\/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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Clinical Research<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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In the case of clinical investigations, they will always comply with the applicable principles and requirements and will be documented in reports that will support the clinical evaluation 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

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Product Compliance<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The collection of clinical and non-clinical data will allow the manufacturer to demonstrate the conformity of the product based on the safety and performance requirements applicable to each.<\/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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If you need help, guidance, or support with the clinical evaluation of your product, please contact us and we will work to develop the best solution.<\/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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The evaluation process must be systematic and objective<\/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-6883","page","type-page","status-publish","hentry"],"yoast_head":"\nClinical evaluation of medical devices - Consultor\u00eda de producto sanitario<\/title>\n<meta name=\"description\" content=\"Clinical evaluation of a medical device is the systematic process of searching for information and analyzing it to demonstrate its compliance\" \/>\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\/clinical-evaluation-of-medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Clinical evaluation of medical devices - 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