{"id":11258,"date":"2023-01-29T16:22:55","date_gmt":"2023-01-29T15:22:55","guid":{"rendered":"https:\/\/lgigroup.com\/?post_type=glossary&p=11258"},"modified":"2025-12-12T11:15:36","modified_gmt":"2025-12-12T10:15:36","slug":"certificate-en-iso-13485","status":"publish","type":"glossary","link":"https:\/\/lgigroup.com\/uk-en\/glossary\/certificate-en-iso-13485\/","title":{"rendered":"Certificate EN ISO 13485"},"content":{"rendered":" \r\n
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ISO 13485 certification for medical devices<\/h1>\r\n <\/div> \r\n <\/div> \r\n <\/div> \r\n <\/div>\r\n \n\n \r\n
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Quality – because good isn’t good enough for us<\/p>\r\n <\/div>\r\n <\/div>\r\n \r\n \r\n <\/div> \r\n <\/div>\r\n \n\n \r\n

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Anyone who develops medical products bears a lot of responsibility – for the safety of patients, the trust of medical teams and compliance with strict rules. Here, \u201cgood\u201d is not enough. Quality must be demonstrably right: in materials, processes and documentation. ISO 13485 is a standard that not only demands reliable standards, but also permanently anchors them in the company.<\/p>\n\r\n <\/div>\r\n <\/div> \r\n <\/div> \r\n <\/div> \r\n <\/section>\r\n \n\n \r\n

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Table of contents<\/h2>\r\n <\/div>\r\n <\/div>\r\n \r\n \r\n <\/div> \r\n <\/div>\r\n \n\n \r\n
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  1. ISO 13485 simply explained<\/li>\n\n\n\n
  2. The key points of the current ISO 13485<\/li>\n\n\n\n
  3. ISO 13485 places these requirements on your company<\/li>\n\n\n\n
  4. How to get your ISO 13485 certificate<\/li>\n\n\n\n
  5. LGI Healthcare solutions stand for certified quality<\/li>\n\n\n\n
  6. Your questions about ISO 13485 certification<\/li>\n<\/ol>\n<\/div><\/div>\n\n\n \r\n
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    ISO 13485 certification: the most important facts in brief<\/h2>\r\n <\/div>\r\n <\/div>\r\n \r\n \r\n <\/div> \r\n <\/div>\r\n \n\n \r\n
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