{"id":1080,"date":"2026-03-12T17:37:35","date_gmt":"2026-03-12T16:37:35","guid":{"rendered":"https:\/\/stadop.sk\/?page_id=1080"},"modified":"2026-04-01T19:08:19","modified_gmt":"2026-04-01T17:08:19","slug":"certifikaty","status":"publish","type":"page","link":"https:\/\/stadop.sk\/en\/certifikaty","title":{"rendered":"Certifik\u00e1ty"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"1080\" class=\"elementor elementor-1080\" data-elementor-settings=\"{&quot;ha_cmc_init_switcher&quot;:&quot;no&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-410b6561 e-flex e-con-boxed e-con e-parent\" data-id=\"410b6561\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8e1dc86 elementor-widget elementor-widget-page-title\" data-id=\"8e1dc86\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"page-title.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\n\t\t<div class=\"hfe-page-title hfe-page-title-wrapper elementor-widget-heading\">\n\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/stadop.sk\/en\">\n\t\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\n\t\t\t\t\t\t\t\t\n\t\t\t\tCertifik\u00e1ty  \n\t\t\t<\/h2> \n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-44f7f159 elementor-widget elementor-widget-text-editor\" data-id=\"44f7f159\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h3>ISO 13485<\/h3><p>V\u00fdrobca Bossklein m\u00e1 certifik\u00e1ciu ISO 13485, ktor\u00fd predstavuje po\u017eiadavky na komplexn\u00fd syst\u00e9m riadenia kvality pre projektovanie a v\u00fdrobu zdravotn\u00edckych pom\u00f4cok. To je prisp\u00f4soben\u00e9 syst\u00e9mu kvality o\u010dak\u00e1vania priemyslu a regula\u010dn\u00fdm po\u017eiadavk\u00e1m. Certifik\u00e1cie ISO 13485 ukazuje, \u017ee v\u00fdrobca je in\u00fd:<\/p><ul><li>Zaviedol syst\u00e9m riadenia kvality, ktor\u00fd je orientovan\u00fd smerom k n\u00e1vrhu, v\u00fdvoja, v\u00fdroby a mont\u00e1\u017ee zdravotn\u00edckych pom\u00f4cok a s\u00favisiacich slu\u017eieb.<\/li><li>Preuk\u00e1zal schopnos\u0165 dod\u00e1va\u0165 zdravotn\u00edcke prostriedky a s\u00favisiace slu\u017eby, ktor\u00e9 sp\u013a\u0148aj\u00fa o\u010dak\u00e1vania z\u00e1kazn\u00edkov a v s\u00falade s regula\u010dn\u00fdmi po\u017eiadavkami.<\/li><li>Boli hodnoten\u00fd, \u017ee organiz\u00e1cia je schopn\u00e1 splni\u0165 o\u010dak\u00e1vania z\u00e1kazn\u00edkov a s\u00fa v s\u00falade s regula\u010dn\u00fdmi po\u017eiadavkami.<\/li><\/ul><p>ISO 13485 nie je \u0161tandardn\u00fd produkt. Je to \u0161tandardn\u00fd postup.<\/p><p>Z tohto d\u00f4vodu je tie\u017e v s\u00falade so v\u0161etk\u00fdmi pr\u00edslu\u0161n\u00fdmi a technick\u00fdmi normami a predpisov.<\/p><h3>Ozna\u010denie CE<\/h3><p>Produkty s\u00fa ozna\u010den\u00e9 CE na po\u017eadovanej \u00farovni a\u017e do triedy IIb zdravotn\u00edckych pom\u00f4cok. Zna\u010dka CE je povinn\u00e9 ozna\u010denie zhody ur\u010dit\u00fdch v\u00fdrobkov pred\u00e1van\u00fdch v r\u00e1mci Eur\u00f3pskeho hospod\u00e1rskeho priestoru (EHP) od roku 1985. V\u00fdrobca m\u00e1 audit ka\u017edoro\u010dne notifikovan\u00fdm org\u00e1nom, s cie\u013eom \u010di s\u00fa pr\u00edsne pokyny dodr\u017eiavan\u00e9.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Certifik\u00e1ty ISO 13485 V\u00fdrobca Bossklein m\u00e1 certifik\u00e1ciu ISO 13485, ktor\u00fd predstavuje po\u017eiadavky na komplexn\u00fd syst\u00e9m riadenia kvality pre projektovanie a v\u00fdrobu zdravotn\u00edckych pom\u00f4cok. To je prisp\u00f4soben\u00e9 syst\u00e9mu kvality o\u010dak\u00e1vania priemyslu a regula\u010dn\u00fdm po\u017eiadavk\u00e1m. Certifik\u00e1cie ISO 13485 ukazuje, \u017ee v\u00fdrobca je in\u00fd: Zaviedol syst\u00e9m riadenia kvality, ktor\u00fd je orientovan\u00fd smerom k n\u00e1vrhu, v\u00fdvoja, v\u00fdroby a mont\u00e1\u017ee<\/p>\n<div class=\"klb-readmore\"><a class=\"c-btn\" href=\"https:\/\/stadop.sk\/en\/certifikaty\">Read More <i class=\"far fa-plus\"><\/i><\/a><\/div>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1080","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/stadop.sk\/en\/wp-json\/wp\/v2\/pages\/1080","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stadop.sk\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/stadop.sk\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/stadop.sk\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/stadop.sk\/en\/wp-json\/wp\/v2\/comments?post=1080"}],"version-history":[{"count":8,"href":"https:\/\/stadop.sk\/en\/wp-json\/wp\/v2\/pages\/1080\/revisions"}],"predecessor-version":[{"id":2438,"href":"https:\/\/stadop.sk\/en\/wp-json\/wp\/v2\/pages\/1080\/revisions\/2438"}],"wp:attachment":[{"href":"https:\/\/stadop.sk\/en\/wp-json\/wp\/v2\/media?parent=1080"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}