{"id":7377,"date":"2025-08-26T20:06:32","date_gmt":"2025-08-26T20:06:32","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/?page_id=7377"},"modified":"2026-07-02T11:54:55","modified_gmt":"2026-07-02T11:54:55","slug":"hakkimizda","status":"publish","type":"page","link":"https:\/\/www.kalitekit.com.tr\/en\/hakkimizda\/","title":{"rendered":"Abaut Us"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"7377\" class=\"elementor elementor-7377\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-312f76f e-flex e-con-boxed e-con e-parent\" data-id=\"312f76f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ce63ea1 elementor-widget elementor-widget-html\" data-id=\"ce63ea1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t\t<style>\r\n.kkp,.kkp 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var(--line);border-bottom:1px solid var(--line)}}\r\n<\/style>\r\n\r\n<main class=\"kkp\">\r\n<section class=\"kkp-hero\"><div class=\"kkp-wrap kkp-hero-grid\"><div><span class=\"kkp-kicker\">KaliteKit Dan\u0131\u015fmanl\u0131k<\/span><h1>T\u0131bbi cihaz kalite ve reg\u00fclasyon s\u00fcre\u00e7lerinde g\u00fcvenilir, uygulanabilir \u00e7\u00f6z\u00fcmler<\/h1><p>ISO 13485, MDR, ISO 14971, \u00dcTS, UDI, EUDAMED ve teknik dok\u00fcmantasyon s\u00fcre\u00e7lerinde; firman\u0131z\u0131n \u00fcr\u00fcn yap\u0131s\u0131na, hedef pazar\u0131na ve ger\u00e7ek \u00e7al\u0131\u015fma ko\u015fullar\u0131na uyarlanm\u0131\u015f dan\u0131\u015fmanl\u0131k deste\u011fi sunuyoruz.<\/p><div class=\"kkp-actions\"><a class=\"kkp-btn kkp-primary\" href=\"https:\/\/www.kalitekit.com.tr\/en\/hizmetler\/\">Explore Our Services<\/a><a class=\"kkp-btn kkp-outline\" href=\"https:\/\/www.kalitekit.com.tr\/en\/iletisim\/\">\u0130leti\u015fime Ge\u00e7in<\/a><\/div><\/div><div class=\"kkp-profile\"><div class=\"kkp-profile-box\"><div class=\"kkp-profile-img\"><img src=\"https:\/\/www.kalitekit.com.tr\/wp-content\/uploads\/2025\/10\/3b77baa5-95b1-4f57-9798-826e59ac82aa.jpeg\" alt=\"KaliteKit kurucusu \u0130brahim Serkan Ceylan\" loading=\"eager\" decoding=\"async\"><\/div><div class=\"kkp-profile-cap\"><strong>\u0130brahim Serkan Ceylan<\/strong><span>Kurucu | T\u0131bbi Cihaz Kalite ve Reg\u00fclasyon Dan\u0131\u015fman\u0131<\/span><\/div><\/div><\/div><\/div><\/section>\r\n<section class=\"kkp-strip\"><div class=\"kkp-wrap kkp-strip-grid\"><div class=\"kkp-strip-item\">ISO 13485<\/div><div class=\"kkp-strip-item\">MDR \/ IVDR<\/div><div class=\"kkp-strip-item\">ISO 14971<\/div><div class=\"kkp-strip-item\">GMP<\/div><div class=\"kkp-strip-item\">\u00dcTS<\/div><div class=\"kkp-strip-item\">UDI &amp; EUDAMED<\/div><\/div><\/section>\r\n\r\n<section class=\"kkp-section\"><div class=\"kkp-wrap kkp-intro\"><div><span class=\"kkp-kicker\">Abaut Us<\/span><div class=\"kkp-head\"><h2>Mevzuat\u0131 yaln\u0131zca anlatm\u0131yor, uygulanabilir sisteme d\u00f6n\u00fc\u015ft\u00fcr\u00fcyoruz<\/h2><\/div><p>KaliteKit Dan\u0131\u015fmanl\u0131k, \u0130brahim Serkan Ceylan taraf\u0131ndan Ankara merkezli olarak y\u00fcr\u00fct\u00fclen; t\u0131bbi cihaz kalite y\u00f6netimi, teknik dok\u00fcmantasyon ve reg\u00fclasyon alanlar\u0131nda hizmet sunan ba\u011f\u0131ms\u0131z bir dan\u0131\u015fmanl\u0131k markas\u0131d\u0131r.<\/p><p>Yakla\u015f\u0131k 15 y\u0131ll\u0131k mesleki deneyim; biyoloji, laboratuvar, mikrobiyoloji, \u00fcretim, kalite y\u00f6netimi ve teknik dok\u00fcmantasyon alanlar\u0131ndaki uygulama bilgisiyle birle\u015ftirilir.<\/p><p>Amac\u0131m\u0131z yaln\u0131zca belge haz\u0131rlamak de\u011fil; firman\u0131n \u00fcr\u00fcn yap\u0131s\u0131na, cihaz s\u0131n\u0131f\u0131na, hedef pazar\u0131na ve mevcut kaynaklar\u0131na uygun, g\u00fcnl\u00fck i\u015fleyi\u015fte ger\u00e7ekten kullan\u0131lan ve s\u00fcrd\u00fcr\u00fclebilen sistemler kurmakt\u0131r.<\/p><div class=\"kkp-quote\">\u201cDenetim i\u00e7in haz\u0131rlanm\u0131\u015f dosyalar de\u011fil, g\u00fcnl\u00fck i\u015fleyi\u015fte \u00e7al\u0131\u015fan sistemler kuruyoruz.\u201d<\/div><\/div><div class=\"kkp-facts\"><div class=\"kkp-fact\"><strong>Merkez<\/strong>\u00c7ankaya \/ Ankara<\/div><div class=\"kkp-fact\"><strong>Uzmanl\u0131k oda\u011f\u0131<\/strong>T\u0131bbi cihaz kalite y\u00f6netimi, MDR teknik dok\u00fcmantasyon ve kay\u0131t s\u00fcre\u00e7leri<\/div><div class=\"kkp-fact\"><strong>\u00c7al\u0131\u015fma modeli<\/strong>T\u00fcrkiye geneli uzaktan destek, proje ihtiyac\u0131na g\u00f6re yerinde \u00e7al\u0131\u015fma<\/div><div class=\"kkp-fact\"><strong>Hizmet yakla\u015f\u0131m\u0131<\/strong>\u015eeffaf kapsam, firmaya \u00f6zel planlama ve uygulamaya dayal\u0131 \u00e7\u0131kt\u0131<\/div><\/div><\/div><\/section>\r\n\r\n<section class=\"kkp-section kkp-soft\"><div class=\"kkp-wrap\"><div class=\"kkp-head\"><span class=\"kkp-kicker\">Neden KaliteKit?<\/span><h2>Firmaya \u00f6zel, \u015feffaf ve s\u00fcrd\u00fcr\u00fclebilir \u00e7al\u0131\u015fma modeli<\/h2><\/div><div class=\"kkp-grid-4\"><article class=\"kkp-card\"><span class=\"kkp-icon\">01<\/span><h3>Firmaya \u00f6zel kapsam<\/h3><p>Cihaz s\u0131n\u0131f\u0131, \u00fcr\u00fcn say\u0131s\u0131, mevcut dok\u00fcmantasyon ve hedef pazar birlikte de\u011ferlendirilir.<\/p><\/article><article class=\"kkp-card\"><span class=\"kkp-icon\">02<\/span><h3>Uygulamaya dayal\u0131 yakla\u015f\u0131m<\/h3><p>Dok\u00fcmanlar\u0131n yaln\u0131zca dosyada bulunmas\u0131 de\u011fil, firma s\u00fcre\u00e7lerinde ger\u00e7ekten kullan\u0131lmas\u0131 hedeflenir.<\/p><\/article><article class=\"kkp-card\"><span class=\"kkp-icon\">03<\/span><h3>A\u00e7\u0131k sorumluluk payla\u015f\u0131m\u0131<\/h3><p>Teslimatlar, kapsam d\u0131\u015f\u0131 i\u015fler, firma girdileri, s\u00fcre ve \u00f6deme ko\u015fullar\u0131 ba\u015ftan netle\u015ftirilir.<\/p><\/article><article class=\"kkp-card\"><span class=\"kkp-icon\">04<\/span><h3>Dijital ve \u00f6l\u00e7eklenebilir \u00e7\u00f6z\u00fcmler<\/h3><p>Yo\u011fun \u00fcr\u00fcn portf\u00f6ylerinde veri haz\u0131rl\u0131\u011f\u0131, kontrol ve toplu kay\u0131t i\u015flemleri dijital ara\u00e7larla desteklenir.<\/p><\/article><\/div><\/div><\/section>\r\n\r\n<section class=\"kkp-section\"><div class=\"kkp-wrap\"><div class=\"kkp-head\"><span class=\"kkp-kicker\">Uzmanl\u0131k Alanlar\u0131<\/span><h2>Hangi konularda destek veriyoruz?<\/h2><\/div><div class=\"kkp-grid-3\"><article class=\"kkp-card\"><h3>ISO 13485<\/h3><p>Kalite y\u00f6netim sistemi kurulumu, revizyonu ve s\u00fcrd\u00fcr\u00fclebilir uygulama deste\u011fi.<\/p><\/article><article class=\"kkp-card\"><h3>MDR \/ IVDR<\/h3><p>S\u0131n\u0131fland\u0131rma, uygunluk de\u011ferlendirme yolu ve mevzuat uyum \u00e7al\u0131\u015fmalar\u0131.<\/p><\/article><article class=\"kkp-card\"><h3>Teknik Dosya<\/h3><p>MDR Ek II ve Ek III yap\u0131s\u0131na uygun teknik dok\u00fcmantasyon haz\u0131rl\u0131\u011f\u0131.<\/p><\/article><article class=\"kkp-card\"><h3>ISO 14971<\/h3><p>T\u0131bbi cihaz risk y\u00f6netimi, risk kontrol\u00fc ve art\u0131k risk de\u011ferlendirmesi.<\/p><\/article><article class=\"kkp-card\"><h3>\u00dcTS \/ UDI \/ EUDAMED<\/h3><p>\u00dcr\u00fcn ana verisi, kay\u0131t haz\u0131rl\u0131\u011f\u0131, veri kontrol\u00fc ve toplu kay\u0131t operasyonlar\u0131.<\/p><\/article><article class=\"kkp-card\"><h3>Denetim ve CAPA<\/h3><p>Uygunsuzluk, k\u00f6k neden, d\u00fczeltici faaliyet ve denetim haz\u0131rl\u0131\u011f\u0131.<\/p><\/article><\/div><\/div><\/section>\r\n\r\n<section class=\"kkp-section kkp-soft\"><div class=\"kkp-wrap\"><div class=\"kkp-head\"><span class=\"kkp-kicker\">Hizmet Verilen Firma T\u00fcrleri<\/span><h2>Kimlerle \u00e7al\u0131\u015f\u0131yoruz?<\/h2><\/div><div class=\"kkp-grid-3\"><article class=\"kkp-card\"><h3>T\u0131bbi cihaz \u00fcreticileri<\/h3><p>MDR, ISO 13485, teknik dosya, risk y\u00f6netimi, PMS, etiket ve IFU \u00e7al\u0131\u015fmalar\u0131.<\/p><\/article><article class=\"kkp-card\"><h3>\u0130thalat\u00e7\u0131 ve ihracat\u00e7\u0131lar<\/h3><p>\u00dcTS, EUDAMED, ekonomik operat\u00f6r y\u00fck\u00fcml\u00fcl\u00fckleri ve dok\u00fcman kontrol\u00fc.<\/p><\/article><article class=\"kkp-card\"><h3>Yeni kurulan firmalar<\/h3><p>S\u0131n\u0131fland\u0131rma, kay\u0131t, kalite sistemi ve ba\u015flang\u0131\u00e7 yol haritas\u0131.<\/p><\/article><article class=\"kkp-card\"><h3>Mevcut sistemini geli\u015ftiren firmalar<\/h3><p>Gap analizi, uygunsuzluk kapatma, revizyon ve denetim haz\u0131rl\u0131\u011f\u0131.<\/p><\/article><article class=\"kkp-card\"><h3>Yo\u011fun \u00fcr\u00fcn portf\u00f6y\u00fcne sahip firmalar<\/h3><p>\u00dcTS, UDI ve EUDAMED i\u00e7in toplu veri haz\u0131rl\u0131\u011f\u0131 ve kay\u0131t operasyonu.<\/p><\/article><article class=\"kkp-card\"><h3>Kalite ve reg\u00fclasyon ekipleri<\/h3><p>Proje bazl\u0131 uzman deste\u011fi, e\u011fitim ve ikinci g\u00f6z kontrol\u00fc.<\/p><\/article><\/div><\/div><\/section>\r\n\r\n<section class=\"kkp-section\"><div class=\"kkp-wrap\"><div class=\"kkp-head\"><span class=\"kkp-kicker\">Proje Y\u00fcr\u00fctme Y\u00f6ntemi<\/span><h2>\u00c7al\u0131\u015fmalar\u0131m\u0131z\u0131 nas\u0131l y\u00fcr\u00fct\u00fcyoruz?<\/h2><\/div><div class=\"kkp-process\"><article class=\"kkp-step\"><h3>\u00d6n g\u00f6r\u00fc\u015fme<\/h3><p>\u00dcr\u00fcn, ihtiya\u00e7, hedef tarih ve mevcut durum de\u011ferlendirilir.<\/p><\/article><article class=\"kkp-step\"><h3>Kapsam analizi<\/h3><p>Gerekli i\u015fler, hari\u00e7 tutulan konular ve firma sorumluluklar\u0131 belirlenir.<\/p><\/article><article class=\"kkp-step\"><h3>Teklif ve planlama<\/h3><p>Teslimatlar, s\u00fcre, \u00f6deme plan\u0131 ve ihtiya\u00e7 duyulan girdiler yaz\u0131l\u0131 sunulur.<\/p><\/article><article class=\"kkp-step\"><h3>Uygulama<\/h3><p>Dok\u00fcmanlar, kay\u0131tlar ve kontroller firma verileriyle haz\u0131rlan\u0131r.<\/p><\/article><article class=\"kkp-step\"><h3>Teslim ve destek<\/h3><p>\u00c7\u0131kt\u0131lar teslim edilir, kullan\u0131m a\u00e7\u0131klan\u0131r ve mutab\u0131k kal\u0131nan destek sa\u011flan\u0131r.<\/p><\/article><\/div><\/div><\/section>\r\n\r\n<section class=\"kkp-section kkp-soft\"><div class=\"kkp-wrap\"><div class=\"kkp-head\"><span class=\"kkp-kicker\">\u00c7al\u0131\u015fma Modeli<\/span><h2>Uzaktan ve yerinde destek<\/h2><\/div><div class=\"kkp-grid-2\"><article class=\"kkp-card\"><h3>Uzaktan \u00e7al\u0131\u015fma<\/h3><p>Dok\u00fcman inceleme, \u00e7evrim i\u00e7i toplant\u0131, proje takibi, e\u011fitim, veri haz\u0131rl\u0131\u011f\u0131 ve dosya olu\u015fturma \u00e7al\u0131\u015fmalar\u0131 T\u00fcrkiye genelinde g\u00fcvenli dijital kanallarla y\u00fcr\u00fct\u00fclebilir.<\/p><\/article><article class=\"kkp-card\"><h3>Yerinde \u00e7al\u0131\u015fma<\/h3><p>Proje kapsam\u0131 ve kar\u015f\u0131l\u0131kl\u0131 planlamaya ba\u011fl\u0131 olarak saha incelemesi, toplant\u0131 veya yerinde dan\u0131\u015fmanl\u0131k ayr\u0131ca tekliflendirilir.<\/p><\/article><\/div><\/div><\/section>\r\n\r\n<section class=\"kkp-section\"><div class=\"kkp-wrap\"><div class=\"kkp-head\"><span class=\"kkp-kicker\">Kapsam ve S\u0131n\u0131rlar<\/span><h2>Sorumluluklar\u0131 a\u00e7\u0131k \u015fekilde tan\u0131ml\u0131yoruz<\/h2><\/div><div class=\"kkp-grid-2\"><div class=\"kkp-scope kkp-positive\"><h3>KaliteKit\u2019in sa\u011flad\u0131\u011f\u0131 destek<\/h3><ul class=\"kkp-list\"><li>Mevcut durum ve dok\u00fcman incelemesi<\/li><li>Proje kapsam\u0131na uygun dok\u00fcmantasyon<\/li><li>\u00dcTS, EUDAMED ve UDI veri haz\u0131rl\u0131\u011f\u0131<\/li><li>Denetim \u00f6ncesi kontrol ve haz\u0131rl\u0131k<\/li><li>Firma personeline rehberlik ve e\u011fitim<\/li><\/ul><\/div><div class=\"kkp-scope kkp-neutral\"><h3>Firma sorumlulu\u011funda kalan konular<\/h3><ul class=\"kkp-list\"><li>Yetkili otorite veya onaylanm\u0131\u015f kurulu\u015f ad\u0131na karar verilmesi<\/li><li>Sertifika veya ba\u015fvurunun kabul edilece\u011fine dair garanti<\/li><li>Sa\u011flanmayan teknik ve klinik verilerin varsay\u0131lmas\u0131<\/li><li>Firman\u0131n resm\u00ee beyan, imza ve uygulama sorumlulu\u011funun devral\u0131nmas\u0131<\/li><li>Test laboratuvar\u0131 veya onaylanm\u0131\u015f kurulu\u015f faaliyeti y\u00fcr\u00fct\u00fclmesi<\/li><\/ul><\/div><\/div><\/div><\/section>\r\n\r\n<section class=\"kkp-section kkp-soft\"><div class=\"kkp-wrap\"><div class=\"kkp-head\"><span class=\"kkp-kicker\">Teklif ve Gizlilik<\/span><h2>\u015eeffaf kapsam, kontroll\u00fc bilgi payla\u015f\u0131m\u0131<\/h2><\/div><div class=\"kkp-grid-2\"><article class=\"kkp-card\"><h3>\u015eeffaf teklif s\u00fcreci<\/h3><p>Tekliflerde kapsam, teslimatlar, firma sorumluluklar\u0131, kapsam d\u0131\u015f\u0131 i\u015fler, tahmini s\u00fcre ve \u00f6deme ko\u015fullar\u0131 a\u00e7\u0131k \u015fekilde belirtilir.<\/p><\/article><article class=\"kkp-card\"><h3>Gizlilik yakla\u015f\u0131m\u0131<\/h3><p>Payla\u015f\u0131lan teknik, ticari ve \u00fcr\u00fcn bilgileri yaln\u0131zca hizmetin y\u00fcr\u00fct\u00fclmesi amac\u0131yla kullan\u0131l\u0131r. Gerekti\u011finde kar\u015f\u0131l\u0131kl\u0131 gizlilik s\u00f6zle\u015fmesi imzalanabilir.<\/p><\/article><\/div><\/div><\/section>\r\n\r\n<section class=\"kkp-section\"><div class=\"kkp-wrap\"><div class=\"kkp-head\"><span class=\"kkp-kicker\">Mesleki E\u011fitimler<\/span><h2>Yetkinli\u011fi destekleyen e\u011fitimler<\/h2><\/div><div class=\"kkp-cert-grid\">\r\n<button class=\"kkp-cert\" type=\"button\" data-cert=\"https:\/\/www.kalitekit.com.tr\/wp-content\/uploads\/2025\/08\/Ekran-Resmi-2025-08-26-23.19.57.png\"><span class=\"kkp-cert-media\"><img decoding=\"async\" src=\"https:\/\/www.kalitekit.com.tr\/wp-content\/uploads\/2025\/08\/Ekran-Resmi-2025-08-26-23.19.57.png\" alt=\"ISO 13485:2016 Ba\u015f Denet\u00e7i \/ Denet\u00e7i E\u011fitimi sertifikas\u0131\" loading=\"lazy\"><\/span><span class=\"kkp-cert-copy\"><strong>ISO 13485:2016 Ba\u015f Denet\u00e7i \/ Denet\u00e7i E\u011fitimi<\/strong><small>ANKA Global<\/small><em>Belgeyi g\u00f6r\u00fcnt\u00fcle<\/em><\/span><\/button>\r\n<button class=\"kkp-cert\" type=\"button\" data-cert=\"https:\/\/www.kalitekit.com.tr\/wp-content\/uploads\/2025\/08\/Ekran-Resmi-2025-08-26-23.20.16.png\"><span class=\"kkp-cert-media\"><img decoding=\"async\" src=\"https:\/\/www.kalitekit.com.tr\/wp-content\/uploads\/2025\/08\/Ekran-Resmi-2025-08-26-23.20.16.png\" alt=\"ISO 13485:2016 \u0130\u00e7 Tetkik\u00e7i E\u011fitimi sertifikas\u0131\" loading=\"lazy\"><\/span><span class=\"kkp-cert-copy\"><strong>ISO 13485:2016 \u0130\u00e7 Tetkik\u00e7i E\u011fitimi<\/strong><small>ANKA Global<\/small><em>Belgeyi g\u00f6r\u00fcnt\u00fcle<\/em><\/span><\/button>\r\n<button class=\"kkp-cert\" type=\"button\" data-cert=\"https:\/\/www.kalitekit.com.tr\/wp-content\/uploads\/2025\/08\/Ekran-Resmi-2025-08-26-23.20.40.png\"><span class=\"kkp-cert-media\"><img decoding=\"async\" src=\"https:\/\/www.kalitekit.com.tr\/wp-content\/uploads\/2025\/08\/Ekran-Resmi-2025-08-26-23.20.40.png\" alt=\"ISO 14971:2019 T\u0131bbi Cihaz Risk Y\u00f6netimi E\u011fitimi sertifikas\u0131\" loading=\"lazy\"><\/span><span class=\"kkp-cert-copy\"><strong>ISO 14971:2019 T\u0131bbi Cihaz Risk Y\u00f6netimi E\u011fitimi<\/strong><small>ANKA Global<\/small><em>Belgeyi g\u00f6r\u00fcnt\u00fcle<\/em><\/span><\/button>\r\n<button class=\"kkp-cert\" type=\"button\" data-cert=\"https:\/\/www.kalitekit.com.tr\/wp-content\/uploads\/2025\/08\/Ekran-Resmi-2025-08-26-23.22.16.png\"><span class=\"kkp-cert-media\"><img decoding=\"async\" src=\"https:\/\/www.kalitekit.com.tr\/wp-content\/uploads\/2025\/08\/Ekran-Resmi-2025-08-26-23.22.16.png\" alt=\"Liderlik Workshop E\u011fitimi sertifikas\u0131\" loading=\"lazy\"><\/span><span class=\"kkp-cert-copy\"><strong>Liderlik Workshop E\u011fitimi<\/strong><small>KIWA<\/small><em>Belgeyi g\u00f6r\u00fcnt\u00fcle<\/em><\/span><\/button>\r\n<button class=\"kkp-cert\" type=\"button\" data-cert=\"https:\/\/www.kalitekit.com.tr\/wp-content\/uploads\/2025\/08\/Ekran-Resmi-2025-08-26-23.22.45.png\"><span class=\"kkp-cert-media\"><img decoding=\"async\" src=\"https:\/\/www.kalitekit.com.tr\/wp-content\/uploads\/2025\/08\/Ekran-Resmi-2025-08-26-23.22.45.png\" alt=\"MDR T\u0131bbi Cihazlar Y\u00f6netmelikleri ve Teknik Dok\u00fcmantasyon E\u011fitimi sertifikas\u0131\" loading=\"lazy\"><\/span><span class=\"kkp-cert-copy\"><strong>MDR T\u0131bbi Cihazlar Y\u00f6netmelikleri ve Teknik Dok\u00fcmantasyon E\u011fitimi<\/strong><small>KIWA<\/small><em>Belgeyi g\u00f6r\u00fcnt\u00fcle<\/em><\/span><\/button>\r\n<button class=\"kkp-cert\" type=\"button\" data-cert=\"https:\/\/www.kalitekit.com.tr\/wp-content\/uploads\/2025\/08\/Ekran-Resmi-2025-08-26-23.23.12-scaled.png\"><span class=\"kkp-cert-media\"><img decoding=\"async\" src=\"https:\/\/www.kalitekit.com.tr\/wp-content\/uploads\/2025\/08\/Ekran-Resmi-2025-08-26-23.23.12-scaled.png\" alt=\"GMP G\u00fcncelleme E\u011fitimi sertifikas\u0131\" loading=\"lazy\"><\/span><span class=\"kkp-cert-copy\"><strong>GMP G\u00fcncelleme E\u011fitimi<\/strong><small>Academia Life Sciences Center<\/small><em>Belgeyi g\u00f6r\u00fcnt\u00fcle<\/em><\/span><\/button>\r\n<\/div><div class=\"kkp-note\">KaliteKit Dan\u0131\u015fmanl\u0131k bir onaylanm\u0131\u015f kurulu\u015f veya kamu otoritesi de\u011fildir. Sunulan hizmetler, firmalar\u0131n kalite y\u00f6netimi ve mevzuat s\u00fcre\u00e7lerine haz\u0131rlanmas\u0131n\u0131 destekler.<\/div><\/div><\/section>\r\n\r\n<section class=\"kkp-section kkp-soft\"><div class=\"kkp-wrap kkp-founder\"><div class=\"kkp-founder-card\"><h3>\u0130brahim Serkan Ceylan<\/h3><p>Kurucu | T\u0131bbi Cihaz Kalite ve Reg\u00fclasyon Dan\u0131\u015fman\u0131<\/p><\/div><div class=\"kkp-founder-copy\"><span class=\"kkp-kicker\">Kurucu<\/span><h2>Mesleki deneyim, uygulama bilgisi ve s\u00fcrekli geli\u015fim<\/h2><p>KaliteKit; kalite y\u00f6netimi, laboratuvar, mikrobiyoloji, \u00fcretim ve teknik dok\u00fcmantasyon alanlar\u0131nda edinilen yakla\u015f\u0131k 15 y\u0131ll\u0131k deneyimin t\u0131bbi cihaz firmalar\u0131n\u0131n ihtiya\u00e7lar\u0131na aktar\u0131lmas\u0131 amac\u0131yla kurulmu\u015ftur.<\/p><p>Mesleki ge\u00e7mi\u015f, g\u00fcncel \u00e7al\u0131\u015fmalar ve sekt\u00f6rel payla\u015f\u0131mlar i\u00e7in LinkedIn profilini do\u011frudan g\u00f6r\u00fcnt\u00fcleyebilirsiniz.<\/p><div class=\"kkp-actions\"><a class=\"kkp-btn kkp-primary\" href=\"https:\/\/tr.linkedin.com\/in\/ibrahim-serkan-ceylan\" target=\"_blank\" rel=\"noopener noreferrer\">LinkedIn Profilini G\u00f6r\u00fcnt\u00fcle<\/a><\/div><\/div><\/div><\/section>\r\n\r\n<section class=\"kkp-section\"><div class=\"kkp-wrap\"><div class=\"kkp-cta\"><h2>Projenizi birlikte de\u011ferlendirelim<\/h2><p>\u00dcr\u00fcn kapsam\u0131n\u0131z\u0131, mevcut dok\u00fcmantasyonunuzu ve ihtiya\u00e7 duydu\u011funuz deste\u011fi payla\u015f\u0131n; uygulanabilir bir yol haritas\u0131 olu\u015ftural\u0131m.<\/p><div class=\"kkp-actions\"><a class=\"kkp-btn kkp-primary\" href=\"https:\/\/www.kalitekit.com.tr\/en\/iletisim\/\">\u0130leti\u015fime Ge\u00e7in<\/a><a class=\"kkp-btn kkp-outline\" href=\"https:\/\/www.kalitekit.com.tr\/en\/hizmetler\/\">T\u00fcm Hizmetleri G\u00f6r\u00fcn<\/a><\/div><\/div><\/div><\/section>\r\n<div class=\"kkp-modal\" aria-hidden=\"true\"><button class=\"kkp-modal-close\" type=\"button\" aria-label=\"Kapat\">\u00d7<\/button><img alt=\"Sertifika b\u00fcy\u00fck g\u00f6r\u00fcn\u00fcm\"><\/div>\r\n<\/main>\r\n<script>(function(){const r=document.querySelector('.kkp');if(!r)return;const m=r.querySelector('.kkp-modal'),i=m.querySelector('img');function c(){m.classList.remove('open');m.setAttribute('aria-hidden','true');i.removeAttribute('src');document.body.style.overflow=''}r.querySelectorAll('.kkp-cert').forEach(b=>b.addEventListener('click',()=>{if(!b.dataset.cert)return;i.src=b.dataset.cert;m.classList.add('open');m.setAttribute('aria-hidden','false');document.body.style.overflow='hidden'}));m.addEventListener('click',e=>{if(e.target===m)c()});m.querySelector('.kkp-modal-close').addEventListener('click',c);document.addEventListener('keydown',e=>{if(e.key==='Escape')c()})})();<\/script>\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>KaliteKit Dan\u0131\u015fmanl\u0131k T\u0131bbi cihaz kalite ve reg\u00fclasyon s\u00fcre\u00e7lerinde g\u00fcvenilir, uygulanabilir \u00e7\u00f6z\u00fcmler ISO 13485, MDR, ISO 14971, \u00dcTS, UDI, EUDAMED ve [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"","ast-site-content-layout":"full-width-container","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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