{"id":15094,"date":"2020-07-17T11:25:51","date_gmt":"2020-07-17T09:25:51","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=15094"},"modified":"2020-07-17T11:25:51","modified_gmt":"2020-07-17T09:25:51","slug":"certification-iso-13485-the-best-for-medical-devices-and-ivd","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2020\/07\/17\/certification-iso-13485-the-best-for-medical-devices-and-ivd\/","title":{"rendered":"ISO 13485: the best certification for medical and in vitro diagnostic medical devices"},"content":{"rendered":"\n<p>The <strong>certification ISO 13485<\/strong> <em>\u201cMedical Devices \u2013 Quality Management Systems\u201d <\/em>identifies a standard for the <strong>Quality Management System <\/strong>specific for companies in the medical sector that includes aspects of the ISO 9001 standard and specific requirements for <strong>medical devices and in vitro diagnostic medical devices <\/strong>sector.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/07\/certificazione-ISO13485-1024x535.png\" alt=\"ISO 13485: the best certification for medical and in vitro diagnostic medical devices word ISO logo\" class=\"wp-image-15057\"\/><figcaption>ISO 13485: the best certification for medical and in vitro diagnostic medical devices<\/figcaption><\/figure>\n\n\n\n<p>The ISO 13485 standard ensures consistency of design, development, production, installation and supply in such a way as to make IVD and medical devices <strong>safe<\/strong> during their use. <\/p>\n\n\n\n<p>Moreover, the ISO 13485 is increasingly in demand <strong>to be the starting point of the application of the international GMP.<\/strong><br>Indeed, the main objective of the ISO 13485 is to favour international harmonization of requirements for medical devices and IVD.<\/p>\n\n\n\n<p>It should be\nremembered that <strong>the ISO 13485 standard<\/strong>\nis a precondition for obtaining the <strong>EC\nmarking<\/strong> in accordance with European directives and having a conforming\nquality system is a prerequisite for manufacturers, critical suppliers,\nauthorised representatives, importers and distributors as established in the <strong>MDR\n(EU) 2017\/745<\/strong> for medical devices\nand in the <strong>IVDR (EU) 2017\/746 <\/strong>for in vitro diagnostic medical devices,\nwhich are regulations that will replace the current directives in the 2021 and\n2022.<\/p>\n\n\n\n<p>It can be stated that companies which decide to apply and certificate a Quality Management System for medical devices and IVD, in accordance with the ISO 13485, demonstrate the will to continuously <strong>improve the effectiveness of their processes <\/strong>and they attest to their abilities <strong>to market secure and effective devices worldwide<\/strong>. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>But to whom exactly does ISO 13485:2016 apply?<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Companies producing third-party brand medical devices but which intend to <strong>start marketing the devices of their behalf in EU markets.<\/strong><\/li><li><strong>In vitro diagnostic medical devices (IVD) <\/strong>manufacturers who want to prepare for the future regulatory obligations of IVDR 2017\/746 and <strong>subject to EC marking<\/strong>.<\/li><li><strong>Medical devices (MD)<\/strong> manufacturers who want to prepare for the future regulatory obligations of MDR 2017\/745 and <strong>subject to EC marking<\/strong>.<\/li><li>Companies that <strong>design, manufacture and assemble<\/strong> medical devices and in vitro diagnostic medical devices.<\/li><li>Enterprise  that distribute and market <strong>medical products<\/strong>.<\/li><li>Companies providing <strong>services related to medical devices<\/strong> (installation, maintenance and repair).<\/li><li>Suppliers of <strong>particular processes associated with the manufacture of medical devices<\/strong> (e.g. sterilization, storage and transport).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>The advantages of the certification ISO 13485<\/strong><\/h2>\n\n\n\n<p>The Quality Management System and the related certification <strong>ISO 13485:2016<\/strong> offer several advantages to companies in the field of medical devices and in vitro diagnostic medical devices. <\/p>\n\n\n\n<p>In summary, for\nany stage of the device\u2019s life cycle, the certified <strong>ISO 13485<\/strong> management\nsystem <strong>helps the company to:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Demonstrate the <strong>compliance with the required standards <\/strong>and\n<strong>meet customer expectations. <\/strong><\/li><li>Certify the <strong>production of safer and more effective\nmedical devices and IVD. <\/strong><\/li><li>Optimize resources by <strong>improving risk and emergency management.<\/strong><\/li><li>Improve processes in the organisation\nand <strong>increase the efficiency<\/strong>.<\/li><li>Expand marketing opportunities\nfor medical devices and IVD both <strong>locally\nand internationally. <\/strong><\/li><li>Achieve <strong>competitive advantage <\/strong>on the ground and globally. <\/li><li><strong>Improve the company image <\/strong>with the consequent\nincrease in stakeholder confidence.<\/li><\/ul>\n\n\n\n<p>Furthermore, in the case of manufacturers of medical devices and in vitro diagnostic medical devices, the application of the ISO 13485:2016 standard gives to the state of the art the <strong>presumption of conformity of the quality system<\/strong> when assessing the requirements for affixing the <strong>EC marking<\/strong> by a Notified Body and it allows a direct and independent audit to prepare for any market surveillance activity carried out by the Ministry of Health.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>How to obtain the ISO 13485 certification?<\/strong><\/h2>\n\n\n\n<p>The procedures to obtain the ISO 13485 certification are rather challenging, and they require considerable investment in resources and time.<\/p>\n\n\n\n<p>Relying on expert consultants is a valid and effective possibility to reach the result in the best possible way, optimizing time and costs.<\/p>\n\n\n\n<p>Thanks to many years of experience, the Thema staff assists its customers in the <strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/quality-and-international-gmps\/\">implementation of the Quality System for medical devices and in vitro diagnostic medical devices<\/a><\/strong>, in accordance with regulatory requirements, providing a complete and modular service including the following activities:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Documentary adjustment of the system to the ISO 13485:2016 requirements; <\/li><li>Pre-audit\/orientative\/gap-analysis\nfor the verification of the Quality Management System;<\/li><li>Assistance during inspections by the Certification Authority;<\/li><li>Post-visit support for the implementation of corrections and preventive\nactions;<\/li><\/ul>\n\n\n\n<p>Do not wait longer: Get immediately prepared for the application of the MDR and IVDR regulations, ensuring your organisation a complete and effective Quality Management System and get the results you want.<br>Contact us for advice! <a href=\"mailto:sales@thema-group.it\">sales@thema-group.it<\/a> &nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The certification ISO 13485 \u201cMedical Devices \u2013 Quality Management Systems\u201d identifies a standard for the Quality Management System specific for companies  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[679],"tags":[],"class_list":["post-15094","post","type-post","status-publish","format-standard","hentry","category-blog-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Certification ISO 13485: the best for medical medical devices and IVD<\/title>\n<meta name=\"description\" content=\"Find out what are the advantages and how to obtain ISO 13485, the best certification for in vitro diagnostic medical and medical devices.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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