{"id":23855,"date":"2026-11-04T10:24:32","date_gmt":"2026-11-04T07:24:32","guid":{"rendered":"https:\/\/mirora.com\/?p=23855"},"modified":"2026-10-20T22:32:37","modified_gmt":"2026-10-20T19:32:37","slug":"tibbi-cihaz-cevirisi-etiketler-kullanim-talimatlari-ve-pazarlarin-dil-gereklilikleri","status":"publish","type":"post","link":"https:\/\/mirora.com\/tr\/tibbi-cihaz-cevirisi-etiketler-kullanim-talimatlari-ve-pazarlarin-dil-gereklilikleri\/","title":{"rendered":"T\u0131bbi Cihaz \u00c7evirisi: Etiketler, Kullan\u0131m Talimatlar\u0131 ve Pazarlar\u0131n Dil Gereklilikleri"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"23855\" class=\"elementor elementor-23855\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-729b653 e-flex e-con-boxed e-con e-parent\" data-id=\"729b653\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\r\n\r\n\t\t<div class=\"elementor-element elementor-element-1eec0878 elementor-widget elementor-widget-text-editor\" data-id=\"1eec0878\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Bir t\u0131bbi cihaz birden fazla \u00fclkede kullan\u0131lmak \u00fczere geli\u015ftirilmi\u015f olabilir. Ancak cihazla birlikte sunulan bilgiler her pazarda ayn\u0131 dilde ve ayn\u0131 bi\u00e7imde kullan\u0131lamaz. Etiketler, kullan\u0131m talimatlar\u0131 ve yaz\u0131l\u0131m aray\u00fczleri; sa\u011fl\u0131k profesyonellerinin ve hastalar\u0131n cihaz\u0131 tan\u0131mas\u0131na, kullan\u0131m amac\u0131n\u0131 anlamas\u0131na ve g\u00fcvenli kullan\u0131m y\u00f6nergelerini izlemesine yard\u0131mc\u0131 olur. Bu bilgilerin ba\u015fka dillere aktar\u0131lmas\u0131nda t\u0131bbi do\u011fruluk, kullan\u0131labilirlik ve mevzuat gereklilikleri birlikte de\u011ferlendirilmelidir.<\/span><\/p><p><span style=\"font-weight: 400;\">Uluslararas\u0131 pazarlara a\u00e7\u0131lan \u00fcreticiler i\u00e7in t\u0131bbi cihaz \u00e7evirisi yaln\u0131zca dilsel bir i\u015flem de\u011fildir. \u00dcr\u00fcn dok\u00fcmantasyonu, mevzuata uyum, teknik uzmanl\u0131k ve dil hizmetlerinin koordinasyonunu gerektirir. Temel ama\u00e7, \u00fcr\u00fcn bilgilerinin anlam\u0131n\u0131 korurken hedef pazar\u0131n ge\u00e7erli gerekliliklerini kar\u015f\u0131lamakt\u0131r.<\/span><\/p><h1><span style=\"font-size: 24px;\"><b>T\u0131bbi Cihaz \u00c7evirisi Neden \u00d6nemlidir?<\/b><\/span><\/h1><p><span style=\"font-weight: 400;\">T\u0131bbi cihaz belgeleri farkl\u0131 kullan\u0131c\u0131 gruplar\u0131na hitap eder. Bir sa\u011fl\u0131k profesyoneli ayr\u0131nt\u0131l\u0131 teknik talimatlara ihtiya\u00e7 duyabilirken evde cihaz kullanan bir hastan\u0131n \u00e7al\u0131\u015ft\u0131rma, \u00f6nlem ve sorun giderme bilgilerini kolayca anlayabilmesi gerekir. Bu nedenle \u00e7eviri hem do\u011fru olmal\u0131 hem de hedef kullan\u0131c\u0131n\u0131n bilgi ve deneyim d\u00fczeyine uygun haz\u0131rlanmal\u0131d\u0131r.<\/span><\/p><p><span style=\"font-weight: 400;\">Avrupa Birli\u011fi\u2019nde 2017\/745 say\u0131l\u0131 T\u0131bbi Cihaz T\u00fcz\u00fc\u011f\u00fc (MDR), \u00fcreticilerin cihazlarla birlikte sunaca\u011f\u0131 bilgilere ili\u015fkin h\u00fck\u00fcmler i\u00e7erir. T\u00fcz\u00fc\u011f\u00fcn Ek I, B\u00f6l\u00fcm 23\u2019\u00fc etiketler ve kullan\u0131m talimatlar\u0131n\u0131 d\u00fczenler. \u0130n vitro tan\u0131 ama\u00e7l\u0131 t\u0131bbi cihazlar i\u00e7inse 2017\/746 say\u0131l\u0131 T\u00fcz\u00fc\u011f\u00fcn (IVDR) Ek I, B\u00f6l\u00fcm 20\u2019si ge\u00e7erlidir. Bu iki d\u00fczenleme birbirinden ayr\u0131d\u0131r; \u00fcretici, \u00fcr\u00fcn\u00fcne hangi h\u00fck\u00fcmlerin uyguland\u0131\u011f\u0131n\u0131 belirlemelidir.<\/span><\/p><h1><span style=\"font-size: 24px;\"><b>Hangi Belgelerin \u00c7evrilmesi Gerekebilir?<\/b><\/span><\/h1><p><span style=\"font-weight: 400;\">\u00c7eviri kapsam\u0131 cihaz\u0131n niteli\u011fine, hedef kullan\u0131c\u0131ya, pazara ve ge\u00e7erli d\u00fczenlemelere g\u00f6re de\u011fi\u015fir. S\u0131k kar\u015f\u0131la\u015f\u0131lan i\u00e7erikler \u015funlard\u0131r:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u00dcr\u00fcn etiketleri ve ambalaj \u00fczerindeki bilgiler<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Kullan\u0131m talimatlar\u0131 ve kullan\u0131c\u0131 k\u0131lavuzlar\u0131<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Uyar\u0131lar, \u00f6nlemler ve g\u00fcvenlik bilgileri<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Yaz\u0131l\u0131m aray\u00fcz\u00fc metinleri ve ekran y\u00f6nergeleri<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Hastalara y\u00f6nelik bilgilendirme ve e\u011fitim materyalleri<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Saha g\u00fcvenlik bildirimleri ve ilgili g\u00fcvenlik duyurular\u0131<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Belirli bir ama\u00e7 i\u00e7in gerekli olan teknik veya mevzuata ili\u015fkin belgeler<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Bu belgelerin tamam\u0131 ayn\u0131 i\u015f ak\u0131\u015f\u0131na tabi tutulmamal\u0131d\u0131r. Baz\u0131lar\u0131 cihazla birlikte sunulurken baz\u0131lar\u0131 d\u00fczenleyici s\u00fcre\u00e7lerde veya sa\u011fl\u0131k profesyonelleriyle ileti\u015fimde kullan\u0131l\u0131r. Uygulama \u00f6nerisi: Her belgenin amac\u0131n\u0131, hedef kitlesini, kullan\u0131laca\u011f\u0131 pazar\u0131, dil gerekliliklerini ve onay sorumlular\u0131n\u0131 i\u00e7eren bir envanter haz\u0131rlay\u0131n.<\/span><\/p><h1><span style=\"font-size: 24px;\"><b>MDR ve IVDR Kapsam\u0131nda AB Dil Gereklilikleri<\/b><\/span><\/h1><p><span style=\"font-weight: 400;\">MDR Madde 10(11), \u00fcreticinin cihazla birlikte Ek I, B\u00f6l\u00fcm 23\u2019te belirtilen bilgileri, cihaz\u0131n kullan\u0131c\u0131ya veya hastaya sunuldu\u011fu \u00fcye devletin belirledi\u011fi resmi AB dilinde ya da dillerinde sa\u011flamas\u0131n\u0131 \u00f6ng\u00f6r\u00fcr. IVDR Madde 10(10) da Ek I, B\u00f6l\u00fcm 20\u2019ye at\u0131fla benzer bir h\u00fck\u00fcm i\u00e7erir. Dolay\u0131s\u0131yla bir AB \u00fclkesinde kabul edilen dil d\u00fczeninin di\u011fer \u00fclkelerde de ge\u00e7erli oldu\u011fu varsay\u0131lmamal\u0131d\u0131r.<\/span><\/p><p><span style=\"font-weight: 400;\">Avrupa Komisyonu, MDR ve IVDR kapsam\u0131ndaki \u00fcye devlet dil gerekliliklerini \u00f6zetleyen ayr\u0131 tablolar yay\u0131mlar. Bu tablolar planlama a\u00e7\u0131s\u0131ndan yararl\u0131d\u0131r; ancak y\u00fcr\u00fcrl\u00fckteki AB mevzuat\u0131n\u0131n ve ulusal h\u00fck\u00fcmlerin yerine ge\u00e7mez. \u00dcreticilerin \u00e7eviri kapsam\u0131n\u0131 kesinle\u015ftirmeden \u00f6nce her \u00fcr\u00fcn ve hedef pazar i\u00e7in g\u00fcncel ko\u015fullar\u0131 do\u011frulamas\u0131 gerekir.<\/span><\/p><h2><span style=\"font-size: 18px;\"><b>T\u0131bbi Cihaz Yaz\u0131l\u0131mlar\u0131n\u0131n Aray\u00fczleri Nas\u0131l Ele Al\u0131nmal\u0131?<\/b><\/span><\/h2><p><span style=\"font-weight: 400;\">Men\u00fcler, hata mesajlar\u0131, ayarlar, uyar\u0131lar ve ekran y\u00f6nergeleri cihaz\u0131n kullan\u0131m\u0131nda \u00f6nemli rol oynayabilir. Avrupa Komisyonunun dil tablolar\u0131nda grafik kullan\u0131c\u0131 aray\u00fczlerine (GUI) ili\u015fkin bilgiler de bulunur. MDR ve IVDR, b\u00fct\u00fcn AB \u00fclkelerinde ge\u00e7erli tek ve \u00f6zel bir aray\u00fcz dili kural\u0131 koymaz; ulusal d\u00fczenlemeler ve cihaz\u0131n \u00f6zellikleri belirleyici olabilir. Bu nedenle yerelle\u015ftirme karar\u0131 kullan\u0131m amac\u0131, kullan\u0131c\u0131 grubu, g\u00fcvenlikle ilgili i\u015flevler ve ilgili \u00fclke h\u00fck\u00fcmleri dikkate al\u0131narak verilmelidir.<\/span><\/p><h1><span style=\"font-size: 24px;\"><b>Etiket \u00c7evirisi: S\u0131n\u0131rl\u0131 Alanda Kritik Bilgiler<\/b><\/span><\/h1><p><span style=\"font-weight: 400;\">Cihaz\u0131n \u00f6zelliklerine ve ge\u00e7erli gerekliliklere ba\u011fl\u0131 olarak etiketlerde tan\u0131mlay\u0131c\u0131 bilgiler, saklama ko\u015fullar\u0131, uyar\u0131lar, son kullanma tarihi veya kullan\u0131mla ilgili y\u00f6nergeler bulunabilir. \u00c7eviri s\u0131ras\u0131nda anlam korunmal\u0131, okunabilirlik bozulmamal\u0131 ve belirsizlik yarat\u0131lmamal\u0131d\u0131r.<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Cihaz ve bile\u015fen adlar\u0131n\u0131 tutarl\u0131 kullan\u0131n.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Uyar\u0131lar\u0131, \u00f6nlemleri, tarihleri, say\u0131lar\u0131 ve \u00f6l\u00e7\u00fc birimlerini kontrol edin.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">K\u0131saltma ve sembollerin ge\u00e7erli gerekliliklere uygunlu\u011funu de\u011ferlendirin.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u00c7evrilmi\u015f metni etiketin ger\u00e7ek tasar\u0131m\u0131 \u00fczerinde inceleyin.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Etiket ile kullan\u0131m talimatlar\u0131 aras\u0131ndaki terminoloji uyumunu koruyun.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Standartla\u015ft\u0131r\u0131lm\u0131\u015f semboller baz\u0131 bilgilerin aktar\u0131lmas\u0131n\u0131 kolayla\u015ft\u0131rabilir; ancak bunlar\u0131n kullan\u0131m\u0131 \u00e7evrilmi\u015f metin gereklili\u011fini her durumda ortadan kald\u0131rmaz. Uygulama \u00f6nerisi: Dil a\u00e7\u0131s\u0131ndan do\u011fru bir metin bile son etiket \u00fczerinde okunmas\u0131 g\u00fc\u00e7le\u015fiyorsa tasar\u0131m a\u00e7\u0131s\u0131ndan yeniden de\u011ferlendirilmelidir.<\/span><\/p><h1><span style=\"font-size: 24px;\"><b>Kullan\u0131m Talimatlar\u0131nda Do\u011fruluk ve Anla\u015f\u0131labilirlik<\/b><\/span><\/h1><p><span style=\"font-weight: 400;\">Kullan\u0131m talimatlar\u0131 cihaz\u0131n \u00e7al\u0131\u015ft\u0131r\u0131lmas\u0131, haz\u0131rlanmas\u0131, bak\u0131m\u0131, sorun giderme ad\u0131mlar\u0131 ve g\u00fcvenlik \u00f6nlemlerini i\u00e7erebilir. \u00c7eviride y\u00f6nergelerin anlam\u0131 ve s\u0131ras\u0131 korunmal\u0131d\u0131r. Zorunlu bir i\u015flemle tavsiye niteli\u011findeki bir ifade birbirine kar\u0131\u015ft\u0131r\u0131lmamal\u0131; uyar\u0131lar\u0131n g\u00fcc\u00fc azalt\u0131lmamal\u0131 ve i\u015flemlerin s\u0131ras\u0131 de\u011fi\u015ftirilerek farkl\u0131 bir uygulama tarif edilmemelidir.<\/span><\/p><p><span style=\"font-weight: 400;\">Metnin dili hedef kullan\u0131c\u0131ya uygun olmal\u0131d\u0131r. E\u011fitimli sa\u011fl\u0131k profesyonellerine y\u00f6nelik teknik bir talimat ile hastalar\u0131n evde kullanaca\u011f\u0131 bir cihaz\u0131n a\u00e7\u0131klamalar\u0131 ayn\u0131 anlat\u0131m d\u00fczeyini gerektirmeyebilir. Hedef kitlenin ba\u015flang\u0131\u00e7ta belirlenmesi, dil uzmanlar\u0131n\u0131n terminoloji ve anla\u015f\u0131labilirlik kararlar\u0131n\u0131 kolayla\u015ft\u0131r\u0131r.<\/span><\/p><h2><span style=\"font-size: 18px;\"><b>Kullan\u0131m Talimatlar\u0131 Elektronik Ortamda Sunulabilir mi?<\/b><\/span><\/h2><p><span style=\"font-weight: 400;\">Elektronik kullan\u0131m talimatlar\u0131, AB\u2019de belirli kurallara ve ko\u015fullara tabidir. Her cihazda dijital belgenin bas\u0131l\u0131 kullan\u0131m talimat\u0131n\u0131n yerine ge\u00e7ebilece\u011fi varsay\u0131lmamal\u0131d\u0131r. Sunum bi\u00e7imine karar verilmeden \u00f6nce ilgili mevzuat, cihaz kategorisi, kullan\u0131c\u0131 grubu ve g\u00fcncel ko\u015fullar kontrol edilmelidir.<\/span><\/p><h1><span style=\"font-size: 24px;\"><b>\u00dcr\u00fcn\u00fcn Ya\u015fam D\u00f6ng\u00fcs\u00fc Boyunca Terminoloji Tutarl\u0131l\u0131\u011f\u0131<\/b><\/span><\/h1><p><span style=\"font-weight: 400;\">Ayn\u0131 \u00fcr\u00fcn terimleri etiketlerde, kullan\u0131m talimatlar\u0131nda, yaz\u0131l\u0131mda, e\u011fitim materyallerinde ve teknik belgelerde yer alabilir. Tutars\u0131zl\u0131klar, \u00f6zellikle kullan\u0131c\u0131lar\u0131n fiziksel kumandalarla ekrandaki komutlar\u0131 e\u015fle\u015ftirmesi gerekti\u011finde kar\u0131\u015f\u0131kl\u0131\u011fa yol a\u00e7abilir. Projeye \u00f6zel terim s\u00f6zl\u00fc\u011f\u00fcnde onayl\u0131 cihaz ve bile\u015fen adlar\u0131, teknik ve klinik terimler, aray\u00fcz ifadeleri, uyar\u0131lar, k\u0131saltmalar ve \u00e7evrilmeden b\u0131rak\u0131lacak terimler bulunabilir.<\/span><\/p><p><span style=\"font-weight: 400;\">Terminoloji kararlar\u0131 ilgili \u00fcr\u00fcn veya konu uzmanlar\u0131nca onaylanmal\u0131d\u0131r. \u00c7eviri bellekleri g\u00fcncellemelerde tutarl\u0131l\u0131\u011f\u0131 desteklese de \u00f6nceki \u00e7eviriler yeni ba\u011flamlar\u0131nda yeniden kontrol edilmelidir.<\/span><\/p><h1><span style=\"font-size: 24px;\"><b>Dilsel Kontrol\u00fcn \u00d6tesinde Kalite G\u00fcvencesi<\/b><\/span><\/h1><p><span style=\"font-weight: 400;\">Ak\u0131c\u0131 bir metin mutlaka do\u011fru de\u011fildir. \u00c7eviri do\u011fal okunmas\u0131na ra\u011fmen hatal\u0131 bir teknik terim, de\u011fi\u015fmi\u015f bir say\u0131sal de\u011fer veya cihaz\u0131n i\u015fleyi\u015fiyle uyu\u015fmayan bir y\u00f6nerge i\u00e7erebilir. Belgenin risk d\u00fczeyine uygun bir kalite s\u00fcrecinde \u015fu kontroller yer alabilir:<\/span><\/p><table><tbody><tr><td style=\"border-style: solid; border-color: #000000;\"><p><b>Kontrol<\/b><\/p><\/td><td style=\"border-style: solid; border-color: #000000;\"><p><b>Kapsam\u0131<\/b><\/p><\/td><\/tr><tr><td style=\"border-style: solid; border-color: #000000;\"><p><b>Kaynak ve hedef metin kar\u015f\u0131la\u015ft\u0131rmas\u0131<\/b><\/p><\/td><td style=\"border-style: solid; border-color: #000000;\"><p><span style=\"font-weight: 400;\">Do\u011fruluk ve eksiksizlik<\/span><\/p><\/td><\/tr><tr><td style=\"border-style: solid; border-color: #000000;\"><p><b>Terminoloji kontrol\u00fc<\/b><\/p><\/td><td style=\"border-style: solid; border-color: #000000;\"><p><span style=\"font-weight: 400;\">Onayl\u0131 \u00fcr\u00fcn terimleriyle tutarl\u0131l\u0131k<\/span><\/p><\/td><\/tr><tr><td style=\"border-style: solid; border-color: #000000;\"><p><b>Say\u0131sal veri kontrol\u00fc<\/b><\/p><\/td><td style=\"border-style: solid; border-color: #000000;\"><p><span style=\"font-weight: 400;\">\u00d6l\u00e7\u00fc birimleri, tarihler ve kritik de\u011ferler<\/span><\/p><\/td><\/tr><tr><td style=\"border-style: solid; border-color: #000000;\"><p><b>Teknik inceleme<\/b><\/p><\/td><td style=\"border-style: solid; border-color: #000000;\"><p><span style=\"font-weight: 400;\">Cihaz\u0131n i\u015flevleri ve kullan\u0131m amac\u0131yla uyum<\/span><\/p><\/td><\/tr><tr><td style=\"border-style: solid; border-color: #000000;\"><p><b>Yerle\u015fim kontrol\u00fc<\/b><\/p><\/td><td style=\"border-style: solid; border-color: #000000;\"><p><span style=\"font-weight: 400;\">Okunabilirlik, semboller ve metin yerle\u015fimi<\/span><\/p><\/td><\/tr><tr><td style=\"border-style: solid; border-color: #000000;\"><p><b>Yaz\u0131l\u0131m testi<\/b><\/p><\/td><td style=\"border-style: solid; border-color: #000000;\"><p><span style=\"font-weight: 400;\">Ekranda g\u00f6r\u00fcn\u00fcm, metin kesilmesi, ba\u011flam ve kullan\u0131labilirlik<\/span><\/p><\/td><\/tr><tr><td style=\"border-style: solid; border-color: #000000;\"><p><b>S\u00fcr\u00fcm kontrol\u00fc<\/b><\/p><\/td><td style=\"border-style: solid; border-color: #000000;\"><p><span style=\"font-weight: 400;\">Kaynak metin ile \u00e7eviri aras\u0131nda izlenebilirlik<\/span><\/p><\/td><\/tr><\/tbody><\/table><p>\u00a0<\/p><p><span style=\"font-weight: 400;\">Dil uzmanlar\u0131 do\u011frulu\u011fu ve terminoloji tutarl\u0131l\u0131\u011f\u0131n\u0131 de\u011ferlendirir. \u00dcr\u00fcn bilgisi veya mevzuat yorumu gerektiren konularda teknik ve d\u00fczenleyici uzmanlar\u0131n incelemesi gerekebilir. Mevzuata uyum konusundaki nihai sorumluluk \u00fcreticide ve hukuken sorumlu di\u011fer taraflardad\u0131r.<\/span><\/p><h1><span style=\"font-size: 24px;\"><b>G\u00fcncellemeler ve \u00c7ok Dilli S\u00fcr\u00fcm Y\u00f6netimi<\/b><\/span><\/h1><p><span style=\"font-weight: 400;\">\u00dcr\u00fcnler geli\u015ftirildik\u00e7e, talimatlar de\u011fi\u015ftirildik\u00e7e veya yeni bilgiler ortaya \u00e7\u0131kt\u0131k\u00e7a belgeler de g\u00fcncellenir. Kaynak metindeki her de\u011fi\u015fiklik birden fazla dili etkileyebilir. Kontroll\u00fc bir s\u00fcre\u00e7te kaynak s\u00fcr\u00fcm, etkilenen dosyalar, hedef diller, \u00e7eviri ve g\u00f6zden ge\u00e7irme durumu ile gerekli onaylar kay\u0131t alt\u0131na al\u0131nmal\u0131d\u0131r.<\/span><\/p><p><span style=\"font-weight: 400;\">Yaz\u0131l\u0131m g\u00fcncellemelerinde \u00e7evrilmi\u015f aray\u00fcz metinlerinin ekranda do\u011fru g\u00f6r\u00fcnt\u00fclendi\u011fi ve anla\u015f\u0131l\u0131r kald\u0131\u011f\u0131 da kontrol edilmelidir. \u00dcreticiler, de\u011fi\u015fikliklerin \u00e7eviri ekiplerine nas\u0131l aktar\u0131laca\u011f\u0131n\u0131 ve onayl\u0131 metinlerin dok\u00fcmantasyon ile kalite s\u00fcre\u00e7lerine nas\u0131l dahil edilece\u011fini tan\u0131mlamal\u0131d\u0131r.<\/span><\/p><h1><span style=\"font-size: 24px;\"><b>T\u0131bbi Cihaz \u00c7evirisi \u0130\u00e7in Pratik Kontrol Listesi<\/b><\/span><\/h1><table><tbody><tr><td style=\"border-style: solid; border-color: #000000;\"><p><b>Alan<\/b><\/p><\/td><td style=\"border-style: solid; border-color: #000000;\"><p><b>Kontrol sorusu<\/b><\/p><\/td><\/tr><tr><td style=\"border-style: solid; border-color: #000000;\"><p><b>Mevzuat \u00e7er\u00e7evesi<\/b><\/p><\/td><td style=\"border-style: solid; border-color: #000000;\"><p><span style=\"font-weight: 400;\">MDR, IVDR veya ba\u015fka bir d\u00fczenleme mi ge\u00e7erli?<\/span><\/p><\/td><\/tr><tr><td style=\"border-style: solid; border-color: #000000;\"><p><b>Hedef pazarlar<\/b><\/p><\/td><td style=\"border-style: solid; border-color: #000000;\"><p><span style=\"font-weight: 400;\">\u00dclke baz\u0131ndaki dil gereklilikleri do\u011fruland\u0131 m\u0131?<\/span><\/p><\/td><\/tr><tr><td style=\"border-style: solid; border-color: #000000;\"><p><b>Belge kapsam\u0131<\/b><\/p><\/td><td style=\"border-style: solid; border-color: #000000;\"><p><span style=\"font-weight: 400;\">Hangi etiketler, talimatlar, aray\u00fczler ve materyaller dahil?<\/span><\/p><\/td><\/tr><tr><td style=\"border-style: solid; border-color: #000000;\"><p><b>Hedef kullan\u0131c\u0131<\/b><\/p><\/td><td style=\"border-style: solid; border-color: #000000;\"><p><span style=\"font-weight: 400;\">\u0130\u00e7erik profesyonellere mi, hastalara m\u0131, her ikisine mi y\u00f6nelik?<\/span><\/p><\/td><\/tr><tr><td style=\"border-style: solid; border-color: #000000;\"><p><b>Terminoloji<\/b><\/p><\/td><td style=\"border-style: solid; border-color: #000000;\"><p><span style=\"font-weight: 400;\">Onayl\u0131 terimler ve referanslar haz\u0131r m\u0131?<\/span><\/p><\/td><\/tr><tr><td style=\"border-style: solid; border-color: #000000;\"><p><b>Kalite kontrolleri<\/b><\/p><\/td><td style=\"border-style: solid; border-color: #000000;\"><p><span style=\"font-weight: 400;\">Dilsel, teknik ve tasar\u0131m kontrollerinin sorumlular\u0131 belirlendi mi?<\/span><\/p><\/td><\/tr><tr><td style=\"border-style: solid; border-color: #000000;\"><p><b>Yaz\u0131l\u0131m yerelle\u015ftirme<\/b><\/p><\/td><td style=\"border-style: solid; border-color: #000000;\"><p><span style=\"font-weight: 400;\">Aray\u00fcz gereklilikleri ve test ihtiya\u00e7lar\u0131 de\u011ferlendirildi mi?<\/span><\/p><\/td><\/tr><tr><td style=\"border-style: solid; border-color: #000000;\"><p><b>S\u00fcr\u00fcm y\u00f6netimi<\/b><\/p><\/td><td style=\"border-style: solid; border-color: #000000;\"><p><span style=\"font-weight: 400;\">Her \u00e7eviri do\u011fru kaynak s\u00fcr\u00fcmle e\u015fle\u015ftirilebiliyor mu?<\/span><\/p><\/td><\/tr><tr><td style=\"border-style: solid; border-color: #000000;\"><p><b>Son onay<\/b><\/p><\/td><td style=\"border-style: solid; border-color: #000000;\"><p><span style=\"font-weight: 400;\">Yay\u0131mlama ve mevzuat incelemesi sorumlular\u0131 tan\u0131ml\u0131 m\u0131?<\/span><\/p><\/td><\/tr><\/tbody><\/table><p>\u00a0<\/p><h1><span style=\"font-size: 24px;\"><b>Uluslararas\u0131 Pazarlar \u0130\u00e7in \u00dcr\u00fcn Bilgilerini Haz\u0131rlamak<\/b><\/span><\/h1><p><span style=\"font-weight: 400;\">T\u0131bbi cihaz \u00e7evirisi, \u00fcr\u00fcn dok\u00fcmantasyonu ve yeni pazarlara giri\u015f planlamas\u0131n\u0131n bir par\u00e7as\u0131 olarak ele al\u0131nd\u0131\u011f\u0131nda daha etkili y\u00fcr\u00fct\u00fcl\u00fcr. Dil gerekliliklerinin erken belirlenmesi, tutarl\u0131 terminoloji, uygun kontroller ve s\u00fcr\u00fcm y\u00f6netimi \u00e7ok dilli belgelerin g\u00fcvenilirli\u011fini destekler.<\/span><\/p><p><span style=\"font-weight: 400;\">Deneyimli bir medikal \u00e7eviri i\u015f orta\u011f\u0131, yetkin dil uzmanlar\u0131n\u0131n koordinasyonu, yap\u0131land\u0131r\u0131lm\u0131\u015f g\u00f6zden ge\u00e7irme s\u00fcre\u00e7leri, terminoloji y\u00f6netimi ve \u00e7ok dilli proje takibiyle katk\u0131 sa\u011flayabilir. Bununla birlikte \u00e7eviri hizmeti, \u00fcreticinin ge\u00e7erli mevzuata uyumu sa\u011flama ve g\u00f6sterme sorumlulu\u011funun yerini almaz. Hedef, \u00fcr\u00fcn bilgilerinin kullan\u0131laca\u011f\u0131 pazarlarda do\u011fru, anla\u015f\u0131l\u0131r ve tutarl\u0131 bi\u00e7imde sunulmas\u0131d\u0131r.<\/span><\/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>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Bir t\u0131bbi cihaz birden fazla \u00fclkede kullan\u0131lmak \u00fczere geli\u015ftirilmi\u015f olabilir. Ancak cihazla birlikte sunulan bilgiler her pazarda ayn\u0131 dilde ve ayn\u0131 bi\u00e7imde kullan\u0131lamaz. Etiketler, kullan\u0131m talimatlar\u0131 ve yaz\u0131l\u0131m aray\u00fczleri; sa\u011fl\u0131k profesyonellerinin ve hastalar\u0131n cihaz\u0131 tan\u0131mas\u0131na, kullan\u0131m amac\u0131n\u0131 anlamas\u0131na ve g\u00fcvenli kullan\u0131m y\u00f6nergelerini izlemesine yard\u0131mc\u0131 olur. <\/p>\n","protected":false},"author":2,"featured_media":23857,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_theme","format":"standard","meta":{"footnotes":""},"categories":[79,81],"tags":[],"class_list":["post-23855","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-ceviri","category-ceviri-kalitesi","th-blog blog-single"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>T\u0131bbi Cihaz \u00c7evirisi: Etiketler, Kullan\u0131m Talimatlar\u0131 ve Pazarlar\u0131n Dil Gereklilikleri- Mirora Translation<\/title>\n<meta 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