{"id":985,"date":"2025-10-21T17:44:56","date_gmt":"2025-10-21T15:44:56","guid":{"rendered":"https:\/\/www.supera-kvaliteta.hr\/medical-devices\/"},"modified":"2025-12-24T16:03:29","modified_gmt":"2025-12-24T15:03:29","slug":"medical-devices","status":"publish","type":"page","link":"https:\/\/www.supera-kvaliteta.hr\/en\/medical-devices\/","title":{"rendered":"Medical devices"},"content":{"rendered":"<section class=\"l-section wpb_row height_medium width_custom\" style=\"--site-content-width:1050px;\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_grid cols_1 laptops-cols_inherit tablets-cols_inherit mobiles-cols_1 valign_top type_default stacking_default\"><div class=\"wpb_column vc_column_container us_custom_af7e40fa has_bg_color\"><div class=\"vc_column-inner\"><div class=\"wpb_text_column h1-small\"><div class=\"wpb_wrapper\"><div class=\"page-header\">\n<h1 style=\"text-align: center;\">Medical devices<\/h1>\n<div class=\"mod_tquote_quote\">\n<blockquote>\n<p><b>&#8220;Happiness does not lie in doing what one wants to do, but in loving what one has to do.&#8221;<\/b> | <i>Sahtya Sai Baba<\/i><\/p>\n<\/blockquote>\n<\/div>\n<\/div>\n<p>SUPERA KVALITETA provides <strong>business consulting services<\/strong><span> <\/span>in the field of<span> <\/span><strong>medical devices<\/strong><\/p>\n<ul>\n<li>implementation of quality management system according to the requirements of ISO 13485:2016 in:\n<ul>\n<li>production<\/li>\n<li>warehousing<\/li>\n<li>servicing of medical devices<\/li>\n<\/ul>\n<\/li>\n<li>implementation, maintenance and improvment of\n<ul>\n<li>Good Manufacturing Practice &#8211; GMP<\/li>\n<li>Good Distribution Practice &#8211; GDP<\/li>\n<\/ul>\n<\/li>\n<li>preparation of product technical documentation including Declaration of Conformity<\/li>\n<li>clinical evaluation<\/li>\n<\/ul>\n<p>We also perform internal<span> <\/span><a href=\"https:\/\/www.supera-kvaliteta.hr\/en\/audits\/\">audits <\/a>and<span> <\/span><span><a href=\"https:\/\/www.supera-kvaliteta.hr\/en\/audits\/\">third-party audits<\/a><\/span><span> <\/span>in compliance with applicable regulatory requirements and standards.<\/p>\n<p>We organize and perform<a href=\"https:\/\/www.supera-kvaliteta.hr\/seminari\/\"> in-house trainings<\/a> in English language for GxP, CE marking and other topics in the field of medical devices.<\/p>\n<\/div><\/div><div class=\"w-gallery fit_cover type_grid action_popup_image ratio_4x3 count_4\" style=\"--columns:4;--items-gap:10px;\"><div class=\"w-gallery-list\"><div class=\"w-gallery-item\"><div class=\"w-gallery-item-img\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/MP_diabetes-528678_1920-1024x683.jpg\" class=\"attachment-large size-large\" alt=\"\" srcset=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/MP_diabetes-528678_1920-1024x683.jpg 1024w, https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/MP_diabetes-528678_1920-300x200.jpg 300w, https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/MP_diabetes-528678_1920.jpg 1920w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/div><a class=\"w-gallery-item-link\" aria-label=\"MP_diabetes-528678_1920\" href=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/MP_diabetes-528678_1920.jpg\"><\/a><\/div><div class=\"w-gallery-item\"><div class=\"w-gallery-item-img\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/MP_hypertension-867855_1920-1024x683.jpg\" class=\"attachment-large size-large\" alt=\"\" srcset=\"https:\/\/www.supera-kvaliteta.hr\/wp-content\/uploads\/2025\/10\/MP_hypertension-867855_1920-1024x683.jpg 1024w, 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