{"id":116407,"date":"2026-05-18T09:15:06","date_gmt":"2026-05-18T07:15:06","guid":{"rendered":"https:\/\/novak-m.com\/?p=116407"},"modified":"2026-05-18T09:15:06","modified_gmt":"2026-05-18T07:15:06","slug":"dobili-smo-iso-13485","status":"publish","type":"post","link":"https:\/\/novak-m.com\/hr\/dobili-smo-iso-13485\/","title":{"rendered":"ISO 13485: standard koji stoji iza na\u0161ih proizvoda"},"content":{"rendered":"

\u0160to zna\u010di ISO 13485?<\/h2>\n

Do sada smo poslovali u skladu sa standardom ISO 9001, koji potvr\u0111uje ure\u0111en sustav upravljanja kvalitetom. S ISO 13485 idemo korak dalje. Posebno je prilago\u0111en zahtjevima medicinske industrije, u kojoj su sigurnost, sljedivost, nadzor nad procesima i dosljedno ispunjavanje regulatornih zahtjeva od klju\u010dne va\u017enosti.<\/p>\n

Jednostavno re\u010deno: ISO 13485 na\u0161a je obveza da ne radimo kompromise kada je rije\u010d o kvaliteti i sigurnosti medicinskih proizvoda.<\/p>\n

\"\"<\/p>\n

\u0160to to zna\u010di za korisnike?<\/h2>\n

Za krajnje korisnike to zna\u010di vi\u0161e od formalne uskla\u0111enosti. To pru\u017ea dodatno jamstvo da na\u0161i procesi razvoja, proizvodnje, kontrole i dokumentiranja zadovoljavaju visoke zahtjeve koji se primjenjuju na sektor medicinskih ure\u0111aja. Certifikat potvr\u0111uje da sustavno upravljamo rizicima, osiguravamo sljedivost materijala i procesa te kontinuirano radimo na pobolj\u0161anjima.<\/p>\n

Istra\u017eite na\u0161e proizvode<\/a><\/div>\n

Uskla\u0111enost s MDR-om<\/h2>\n

Na\u0161i proizvodi tako\u0111er su uskla\u0111eni s europskom Uredbom o medicinskim proizvodima (MDR). U kombinaciji s ISO 13485 to zna\u010di da ne slijedimo samo dobre prakse, ve\u0107 ispunjavamo i najnovije zakonske zahtjeve<\/strong><\/a> europskog tr\u017ei\u0161ta. Za korisnike je to dodatno jamstvo da koriste kvalitetnu i pouzdanu opremu.<\/p>\n

Korak naprijed<\/h2>\n

Ponosni smo \u0161to smo stjecanjem certifikata ISO 13485 potvrdili svoju predanost kvaliteti, sigurnosti i pouzdanosti. Na\u0161 cilj ostaje isti: korisnicima \u2014 medicinskom osoblju i pacijentima \u2014 pru\u017eati proizvode i rje\u0161enja kojima mogu vjerovati.<\/p>\n

pi\u0161ite nam<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"

Uspje\u0161no smo dobili certifikat ISO 13485, me\u0111unarodno priznati standard sustava upravljanja kvalitetom za organizacije koje djeluju u podru\u010dju medicinskih proizvoda i medicinske opreme.<\/p>\n","protected":false},"author":5,"featured_media":116381,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[479],"tags":[],"class_list":["post-116407","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-vijesti"],"acf":[],"yoast_head":"\nDobili smo ISO 13485 \u2502 Novak M<\/title>\n<meta name=\"description\" content=\"ISO 13485 na\u0161a je obveza da ne radimo kompromise kada je rije\u010d o kvaliteti i sigurnosti medicinskih proizvoda.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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