{"id":536,"date":"2026-02-10T10:55:43","date_gmt":"2026-02-10T07:55:43","guid":{"rendered":"https:\/\/www.bplussolutions.com\/?p=536"},"modified":"2026-05-15T11:51:10","modified_gmt":"2026-05-15T08:51:10","slug":"literature-search-clinical-evaluation-medical-devices","status":"publish","type":"post","link":"https:\/\/www.bplussolutions.com\/tr\/literature-search-clinical-evaluation-medical-devices\/","title":{"rendered":"T\u0131bbi Cihazlar \u0130\u00e7in Klinik De\u011ferlendirme Literat\u00fcr Taramas\u0131 Nas\u0131l Yap\u0131l\u0131r\nReg\u00fclasyon ve klinik i\u015fler ekipleri i\u00e7in pratik bir rehber"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"536\" class=\"elementor elementor-536\" data-elementor-settings=\"{&quot;element_pack_global_tooltip_width&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;element_pack_global_tooltip_width_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;element_pack_global_tooltip_width_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;element_pack_global_tooltip_padding&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_padding_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_padding_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_border_radius&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_border_radius_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true},&quot;element_pack_global_tooltip_border_radius_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;top&quot;:&quot;&quot;,&quot;right&quot;:&quot;&quot;,&quot;bottom&quot;:&quot;&quot;,&quot;left&quot;:&quot;&quot;,&quot;isLinked&quot;:true}}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1fe9e3d8 e-flex e-con-boxed e-con e-parent\" data-id=\"1fe9e3d8\" data-element_type=\"container\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4e99604 elementor-widget elementor-widget-text-editor\" data-id=\"4e99604\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<h2>Neden \u00f6nemli<\/h2><p style=\"font-weight: 400;\">T\u0131bbi cihaz \u00fcretiyor ve AB pazar\u0131na girmek istiyorsan\u0131z, Klinik De\u011ferlendirme Raporu (CER) atlanabilecek bir ad\u0131m de\u011fil. CER, Onaylanm\u0131\u015f Kurulu\u015flar\u0131n en yak\u0131ndan inceledi\u011fi belgelerden biri. Literat\u00fcr taramas\u0131 da bu raporun belkemi\u011fini olu\u015fturuyor. Bu k\u0131s\u0131mda hata yaparsan\u0131z CE i\u015faretiniz aylarca gecikebilir. Do\u011fru yaparsan\u0131z elinizde g\u00fcvenlik ve performans iddialar\u0131n\u0131z\u0131 destekleyen, denetime haz\u0131r, savunulabilir bir kay\u0131t olur.<\/p><p style=\"font-weight: 400;\">Bu yaz\u0131, ger\u00e7ekten incelemeden ge\u00e7ecek bir literat\u00fcr taramas\u0131n\u0131n nas\u0131l planlanaca\u011f\u0131n\u0131, nas\u0131l y\u00fcr\u00fct\u00fclece\u011fini ve nas\u0131l belgelenece\u011fini anlat\u0131yor. \u0130lk CER'ini haz\u0131rlayan ya da rutin olarak g\u00fcncelledi\u011fi bir CER'i iyile\u015ftirmeye \u00e7al\u0131\u015fan klinik ve reg\u00fclasyon uzmanlar\u0131 i\u00e7in yaz\u0131ld\u0131.<\/p><h2>Klinik de\u011ferlendirme tam olarak nedir<\/h2><p style=\"font-weight: 400;\">Klinik de\u011ferlendirme bir defal\u0131k bir i\u015f de\u011fil, s\u00fcreklilik gerektiren bir s\u00fcre\u00e7. Klinik veri topluyor, bu veriyi de\u011ferlendiriyor, analiz ediyor ve cihaz\u0131n\u0131z\u0131n ya\u015fam d\u00f6ng\u00fcs\u00fc boyunca g\u00fcvenli ve amaca uygun \u00e7al\u0131\u015ft\u0131\u011f\u0131n\u0131 g\u00f6stermek i\u00e7in kullan\u0131yorsunuz (GHTF Study Group 5, 2007; MDR Ek XIV).<\/p><p style=\"font-weight: 400;\">Literat\u00fcr taramas\u0131; klinik ara\u015ft\u0131rma ve pazara s\u00fcr\u00fcm sonras\u0131 klinik takip (PMCF) ile birlikte \u00fc\u00e7 ana klinik veri kayna\u011f\u0131ndan biri. Eski cihazlar\u0131n \u00e7o\u011fu ve d\u00fc\u015f\u00fck ila orta riskli cihazlar\u0131n b\u00fcy\u00fck b\u00f6l\u00fcm\u00fc i\u00e7in, yay\u0131mlanm\u0131\u015f literat\u00fcr y\u00fck\u00fcn \u00f6nemli bir k\u0131sm\u0131n\u0131 ta\u015f\u0131r (MEDDEV 2.7\/1 rev. 4, 2016).<\/p><p style=\"font-weight: 400;\">Yap\u0131land\u0131r\u0131lm\u0131\u015f bir metodolojiye dayanmayan bir tarama, Onaylanm\u0131\u015f Kurulu\u015f incelemesini ge\u00e7emez. Kar\u015f\u0131laman\u0131z gereken \u00fc\u00e7 kriter var: tekrarlanabilirlik, izlenebilirlik ve bilimsel ge\u00e7erlilik (Pati &amp; Lorusso, 2017).<\/p><h2>Ad\u0131m 1: Klinik soruyu tan\u0131mlay\u0131n<\/h2><p style=\"font-weight: 400;\">Tam olarak hangi soruyu sordu\u011funuzu bilmeden iyi bir tarama stratejisi yazamazs\u0131n\u0131z. CER'lerin \u00e7o\u011fu burada yanl\u0131\u015fa gider \u00e7\u00fcnk\u00fc soru ya \u00e7ok genel oluyor (\"bu kateter g\u00fcvenli midir?\") ya da i\u015fe yarayacak kadar somut de\u011fil.<\/p><p style=\"font-weight: 400;\">PICO \u00e7er\u00e7evesi burada yard\u0131mc\u0131 olur. PICO; Hasta (Patient), M\u00fcdahale (Intervention), Kar\u015f\u0131la\u015ft\u0131r\u0131c\u0131 (Comparator) ve Sonu\u00e7 (Outcome) kelimelerinin ba\u015f harfleridir (Ecker &amp; Skelly, 2010). Bir klinik de\u011ferlendirmede genellikle en az iki PICO sorusuna ihtiyac\u0131n\u0131z olur: biri cihaz\u0131n\u0131za ya da e\u015fde\u011fer cihaza odakl\u0131, di\u011feri sanat\u0131n g\u00fcncel durumuna odakl\u0131. \u0130kincisi klinik ba\u011flam\u0131, bak\u0131m standard\u0131n\u0131 ve alternatif tedavileri kapsar.<\/p><p style=\"font-weight: 400;\">Somut bir \u00f6rnek \u00fczerinden gidelim. Y\u00fczeyel femoral arterde kullan\u0131lmak \u00fczere balonla geni\u015fleyen bir periferik stent de\u011ferlendiriyorsunuz diyelim:<\/p><ul><li>P: Y\u00fczeyel femoral arterde semptomatik periferik arter hastal\u0131\u011f\u0131 (Rutherford 2 ila 4) olan yeti\u015fkin hastalar<\/li><li>I: Balonla geni\u015fleyen nitinol stent<\/li><li>C: \u0130la\u00e7 kapl\u0131 balon anjiyoplasti<\/li><li>O: 12. ayda birincil a\u00e7\u0131kl\u0131k, hedef lezyon revask\u00fclarizasyonu, maj\u00f6r advers ekstremite olaylar\u0131<\/li><\/ul><p style=\"font-weight: 400;\">Bu soru aranabilir bir soru. Ayn\u0131 zamanda hangi kar\u015f\u0131la\u015ft\u0131r\u0131c\u0131 literat\u00fcre ihtiyac\u0131n\u0131z oldu\u011funu da s\u00f6yl\u00fcyor (ila\u00e7 kapl\u0131 balonlar). \u0130ncelemecilerin s\u0131kl\u0131kla eksik buldu\u011fu nokta tam olarak buras\u0131.<\/p><h2>Ad\u0131m 2: Savunabilece\u011finiz bir tarama stratejisi kurun<\/h2><p style=\"font-weight: 400;\">\u0130yi bir tarama stratejisi, ikinci bir ki\u015finin ayn\u0131 stratejiyi \u00e7al\u0131\u015ft\u0131r\u0131p ayn\u0131 sonu\u00e7lara ula\u015fabilece\u011fi bir stratejidir. Bu da taramaya ba\u015flamadan \u00f6nce \u015funlar\u0131 yaz\u0131l\u0131 hale getirmeniz gerekti\u011fi anlam\u0131na gelir:<\/p><ul><li>Tam anahtar kelimeler ve e\u015f anlaml\u0131lar\u0131, uygun oldu\u011funda MeSH terimleri dahil<\/li><li>Bunlar\u0131 birbirine ba\u011flayan Boolean mant\u0131\u011f\u0131<\/li><li>Sorgulanacak veri tabanlar\u0131 ve kay\u0131t sistemleri<\/li><li>Tarih aral\u0131\u011f\u0131 ve varsa dil k\u0131s\u0131tlamalar\u0131<\/li><li>Dahil etme ve d\u0131\u015flama kriterleri<\/li><li>Ka\u00e7 incelemecinin \u00e7al\u0131\u015faca\u011f\u0131 ve anla\u015fmazl\u0131klar\u0131n nas\u0131l \u00e7\u00f6z\u00fclece\u011fi<\/li><\/ul><p style=\"font-weight: 400;\">Veri tabanlar\u0131 konusunda; tek ba\u015f\u0131na PubMed yeterli de\u011fil. MEDDEV 2.7\/1 rev. 4 birden fazla kaynak bekler. Pratikte CER'lerin \u00e7o\u011fu PubMed\/MEDLINE, Embase ve Cochrane Library kombinasyonunu kullan\u0131r. Baz\u0131 cihaz s\u0131n\u0131flar\u0131nda ek olarak \u015funlar\u0131 da taraman\u0131z gerekir:<\/p><ul><li>Devam eden veya yay\u0131mlanmam\u0131\u015f \u00e7al\u0131\u015fmalar i\u00e7in ClinicalTrials.gov ve AB Klinik Ara\u015ft\u0131rma Sicili<\/li><li>Advers olay sinyalleri i\u00e7in FDA MAUDE ve EUDAMED<\/li><li>Uluslararas\u0131 pazara s\u00fcr\u00fcm sonras\u0131 veriler i\u00e7in TGA DAEN, Health Canada MDPL gibi ulusal d\u00fczenleyici veri tabanlar\u0131<\/li><li>Yeni geli\u015fen kan\u0131tlar i\u00e7in kongre bildirileri ve gri literat\u00fcr<\/li><\/ul><p style=\"font-weight: 400;\">Bir denetim izi tutun. Ham tarama dizelerini, her tarama tarihini, sonu\u00e7 say\u0131s\u0131n\u0131 ve uygulanan filtreleri kaydedin. Onaylanm\u0131\u015f Kurulu\u015flar bunlar\u0131 rutin olarak ister. Taramay\u0131 tekrar \u00fcretemiyorsan\u0131z CER'in geri kalan\u0131 da savunulmas\u0131 zor bir hale gelir.<\/p><h2>Ad\u0131m 3: Hangi klinik veriyi dahil edece\u011finize karar verin<\/h2><p style=\"font-weight: 400;\">Klinik veri; klinik ara\u015ft\u0131rmalardan, bilimsel literat\u00fcrden, pazara s\u00fcr\u00fcm sonras\u0131 verilerden veya e\u015fde\u011fer cihazlardan gelebilir (GHTF Study Group 5, 2007; MDR Madde 61).<\/p><p style=\"font-weight: 400;\">Her kayna\u011f\u0131n g\u00fc\u00e7l\u00fc ve zay\u0131f yanlar\u0131 var:<\/p><ul><li>Randomize kontroll\u00fc \u00e7al\u0131\u015fmalar tekil olarak en g\u00fc\u00e7l\u00fc \u00e7al\u0131\u015fmalard\u0131r, ancak \u00e7o\u011fu cihaz kategorisinde nadirdir<\/li><li>Sistematik derlemeler ve meta-analizler bulgular\u0131 \u00e7al\u0131\u015fmalar aras\u0131nda b\u00fct\u00fcnle\u015ftirir ve genellikle tekil \u00e7al\u0131\u015fmalara tercih edilir (Pati &amp; Lorusso, 2017).<\/li><li>Kay\u0131t sistemi verileri ve ger\u00e7ek d\u00fcnya verileri \u00f6zellikle uzun vadeli g\u00fcvenlik sinyalleri i\u00e7in giderek daha fazla kabul g\u00f6r\u00fcyor (Valla ve ark., 2023).<\/li><li>Vaka serileri ve vaka raporlar\u0131 tek ba\u015f\u0131na zay\u0131ft\u0131r ama advers olay tespitinde i\u015fe yarar.<\/li><\/ul><p style=\"font-weight: 400;\">Ba\u015fka bir cihazla e\u015fde\u011ferlik \u00fczerinden ilerliyorsan\u0131z, o cihaza ait literat\u00fcr say\u0131l\u0131r, ancak yaln\u0131zca MDR Ek XIV B\u00f6l\u00fcm A do\u011frultusunda teknik, biyolojik ve klinik \u00f6zellikler bak\u0131m\u0131ndan e\u015fde\u011ferli\u011fi ger\u00e7ekten g\u00f6sterebiliyorsan\u0131z. MDR alt\u0131nda bu e\u015fik MDD'ye g\u00f6re \u00e7ok daha y\u00fcksek. \u00dcreticilerin \u00f6nemli bir k\u0131sm\u0131 bunu hafife al\u0131yor.<\/p><h2>Ad\u0131m 4: Kan\u0131t\u0131 de\u011ferlendirin<\/h2><p style=\"font-weight: 400;\">\u00c7al\u0131\u015fmalar\u0131 bulmak i\u015fin sadece ba\u015flang\u0131c\u0131. Her birinin metodolojik kalite, ilgililik ve yanl\u0131l\u0131k riski a\u00e7\u0131s\u0131ndan de\u011ferlendirilmesi gerekiyor.<\/p><p style=\"font-weight: 400;\">Zorunlu k\u0131l\u0131nan tek bir de\u011ferlendirme arac\u0131 yok ama yayg\u0131n kabul g\u00f6ren birka\u00e7 ara\u00e7 var:<\/p><ul><li>H\u0131zl\u0131 s\u0131ralama i\u00e7in Oxford Centre for Evidence-Based Medicine kan\u0131t d\u00fczeyleri<\/li><li>Bir literat\u00fcr b\u00fct\u00fcn\u00fc i\u00e7inde kan\u0131t kesinli\u011fini de\u011ferlendirmek i\u00e7in GRADE<\/li><li>Sistematik derlemeler i\u00e7in AMSTAR 2<\/li><li>Randomize kontroll\u00fc \u00e7al\u0131\u015fmalar i\u00e7in Cochrane RoB 2<\/li><li>M\u00fcdahale i\u00e7eren randomize olmayan \u00e7al\u0131\u015fmalar i\u00e7in ROBINS-I<\/li><\/ul><p style=\"font-weight: 400;\">En \u00f6nemli \u015fey tutarl\u0131l\u0131k. Ayn\u0131 de\u011ferlendirme kriterlerini dahil edilen t\u00fcm \u00e7al\u0131\u015fmalar i\u00e7in kullan\u0131n, her karar i\u00e7in gerek\u00e7eyi belgeleyin ve ikinci bir incelemecinin onay\u0131n\u0131 al\u0131n.<\/p><p style=\"font-weight: 400;\">\u00c7al\u0131\u015fmalar\u0131n d\u00fc\u015f\u00fck puan almas\u0131n\u0131n yayg\u0131n nedenleri \u015funlar:<\/p><ul><li>G\u00fc\u00e7 hesaplamas\u0131 olmadan yap\u0131lan k\u00fc\u00e7\u00fck \u00f6rneklem \u00e7al\u0131\u015fmalar\u0131<\/li><li>Klinik anlam\u0131 olan sonu\u00e7lar yerine vekil son noktalar<\/li><li>\u00d6zellikle retrospektif kay\u0131t analizlerinde se\u00e7im yanl\u0131l\u0131\u011f\u0131<\/li><li>Ba\u011f\u0131ms\u0131z denetim olmadan sekt\u00f6r finansman\u0131<\/li><li>Cihaz\u0131n\u0131z\u0131n ama\u00e7lanan kullan\u0131m\u0131 veya iddialar\u0131yla \u00f6rt\u00fc\u015fmeyen sonu\u00e7lar<\/li><\/ul><h2>Ad\u0131m 5: Veriyi analiz edin ve sentezleyin<\/h2><p style=\"font-weight: 400;\">De\u011ferlendirme bittikten sonra kan\u0131t b\u00fct\u00fcn\u00fcn\u00fc bir araya getiriyor ve Kullan\u0131m Talimatlar\u0131n\u0131zda, pazarlaman\u0131zda ve risk y\u00f6netimi dok\u00fcmantasyonunuzda iddia ettiklerinizi ger\u00e7ekten destekleyip desteklemedi\u011fini soruyorsunuz.<\/p><p style=\"font-weight: 400;\">CER'in sentez b\u00f6l\u00fcm\u00fc, fayda-risk dengesinin kuruldu\u011fu yerdir. \u015eunlar\u0131 yapman\u0131z gerekiyor:<\/p><ul><li>Literat\u00fcrde raporlanan klinik performans\u0131 sizin performans iddialar\u0131n\u0131zla kar\u015f\u0131la\u015ft\u0131r\u0131n<\/li><li>Literat\u00fcr\u00fcn yeterince ele almad\u0131\u011f\u0131 kal\u0131nt\u0131 riskleri tan\u0131mlay\u0131n<\/li><li>Zarar sinyallerini, \u00f6zellikle cihaza \u00f6zg\u00fc olanlar\u0131 i\u015faretleyin<\/li><li>Cihaz\u0131n\u0131z\u0131n sonu\u00e7lar\u0131n\u0131 plaseboyla de\u011fil g\u00fcncel bak\u0131m standard\u0131yla kar\u015f\u0131la\u015ft\u0131r\u0131n<\/li><\/ul><p style=\"font-weight: 400;\">Literat\u00fcr bir konuyu kapsam\u0131yorsa bunu a\u00e7\u0131k\u00e7a s\u00f6yleyin. Tan\u0131mlanm\u0131\u015f ve \u00f6rne\u011fin planlanm\u0131\u015f bir PMCF faaliyetiyle ele al\u0131nm\u0131\u015f bir zay\u0131fl\u0131\u011f\u0131 savunmak, hi\u00e7 bahsedilmemi\u015f bir zay\u0131fl\u0131\u011f\u0131 savunmaktan \u00e7ok daha kolay.<\/p><p style=\"font-weight: 400;\">Sonu\u00e7lar, MDR Ek II kapsam\u0131ndaki teknik dok\u00fcmantasyonunuzun i\u00e7ine giren CER'e i\u015flenir.<\/p><h2>Ad\u0131m 6: Taramay\u0131 canl\u0131 tutun<\/h2><p style=\"font-weight: 400;\">MDR, klinik de\u011ferlendirmeyi tek seferlik bir ba\u015fvuru olarak de\u011fil, ya\u015fam d\u00f6ng\u00fcs\u00fc boyunca s\u00fcren bir y\u00fck\u00fcml\u00fcl\u00fck olarak ele al\u0131r. Literat\u00fcr taramas\u0131n\u0131n d\u00fczenli olarak g\u00fcncellenmesi gerekir. S\u0131kl\u0131k, cihaz\u0131n risk s\u0131n\u0131f\u0131na ve PMCF plan\u0131nda verdi\u011finiz taahh\u00fcde ba\u011fl\u0131d\u0131r. Yine de daha y\u00fcksek riskli cihazlar i\u00e7in y\u0131ll\u0131k g\u00fcncelleme tipik bir uygulama. \u0130mplante edilebilir veya S\u0131n\u0131f III cihazlar i\u00e7in daha s\u0131k g\u00fcncelleme bekleniyor.<\/p><p style=\"font-weight: 400;\">Erken g\u00fcncellemeyi tetiklemesi gereken durumlar:<\/p><ul><li>Pazara s\u00fcr\u00fcm sonras\u0131 g\u00f6zetim sisteminizden gelen bir g\u00fcvenlik sinyali<\/li><li>Benzer bir cihaz veya teknikle ilgili, g\u00fcncel sanat\u0131n durumunu de\u011fi\u015ftiren yeni bir yay\u0131n<\/li><li>\u0130lgili t\u0131p derne\u011finden \u00e7\u0131kan yeni bir klinik k\u0131lavuz<\/li><li>Cihaz\u0131n\u0131z\u0131n ama\u00e7lanan kullan\u0131m\u0131nda, iddialar\u0131nda veya tasar\u0131m\u0131nda bir de\u011fi\u015fiklik<\/li><li>Benzer bir cihazla ilgili reg\u00fclatif bir aksiyon (geri \u00e7a\u011f\u0131rma, saha g\u00fcvenlik bildirimi)<\/li><\/ul><p style=\"font-weight: 400;\">Ger\u00e7ek d\u00fcnya verisi, kay\u0131t sistemi verisi ve hastan\u0131n bildirdi\u011fi sonu\u00e7lar geleneksel literat\u00fcr\u00fc tamamlamak i\u00e7in giderek daha fazla kullan\u0131l\u0131yor. Onaylanm\u0131\u015f Kurulu\u015flar da \u00fcreticilerin bunlar\u0131 nas\u0131l entegre etti\u011fine daha \u00e7ok dikkat ediyor (Valla ve ark., 2023).<\/p><h2>Onaylanm\u0131\u015f Kurulu\u015flar\u0131n s\u0131k yazd\u0131\u011f\u0131 eksiklikler<\/h2><p style=\"font-weight: 400;\">Yeterince Onaylanm\u0131\u015f Kurulu\u015f g\u00f6r\u00fc\u015f\u00fc okudu\u011funuzda ayn\u0131 sorunlar tekrar tekrar kar\u015f\u0131n\u0131za \u00e7\u0131kar:<\/p><ul><li>Tarama dizeleri tekrar \u00fcretilebilir de\u011fil veya hi\u00e7 belgelenmemi\u015f.<\/li><li>\u00dcreticinin e\u015fde\u011ferlik iddia etti\u011fi kar\u015f\u0131la\u015ft\u0131r\u0131c\u0131y\u0131 literat\u00fcr kapsam\u0131yor.<\/li><li>G\u00fcncel sanat taramas\u0131 ya eksik ya da sonradan eklenmi\u015f gibi duruyor.<\/li><li>Dahil etme ve d\u0131\u015flama kriterleri sonradan, taramadan \u00f6nce de\u011fil sonra tan\u0131mlanm\u0131\u015f.<\/li><li>De\u011ferlendirme tutars\u0131z veya tek incelemeciyle yap\u0131lm\u0131\u015f.<\/li><li>Sonu\u00e7, sunulan veriden ger\u00e7ekten \u00e7\u0131km\u0131yor.<\/li><li>Taramay\u0131 g\u00fcncelleme plan\u0131 yok, PMCF ile entegrasyon yok.<\/li><\/ul><p style=\"font-weight: 400;\">Bunlar\u0131n \u00e7o\u011fu veri sorunu de\u011fil, s\u00fcre\u00e7 sorunu. \u00c7\u00f6z\u00fcm, tarama protokol\u00fcn\u00fc taramaya ba\u015flamadan \u00f6nce yazmak ve CER'i canl\u0131 bir belge olarak ele almak.<\/p><h2>Pratik \u00f6neriler<\/h2><p style=\"font-weight: 400;\">S\u00fcreci pratikte kolayla\u015ft\u0131ran birka\u00e7 \u015fey var.<\/p><p style=\"font-weight: 400;\">Taramay\u0131 ba\u015ftan iki incelemeciyle y\u00fcr\u00fct\u00fcn. Onaylanm\u0131\u015f Kurulu\u015f eksikli\u011finden sonra tekrar yapma maliyetine k\u0131yasla zaman maliyeti \u00e7ok d\u00fc\u015f\u00fck kal\u0131r.<\/p><p style=\"font-weight: 400;\">Kaynak y\u00f6netim yaz\u0131l\u0131m\u0131 kullan\u0131n. Zotero, EndNote, Mendeley veya Covidence ya da Rayyan gibi sistematik derlemeye \u00f6zel ara\u00e7lar bu i\u015fi \u00e7ok kolayla\u015ft\u0131r\u0131r. Birka\u00e7 y\u00fcz sonu\u00e7tan sonra manuel takip \u00e7al\u0131\u015fmaz.<\/p><p style=\"font-weight: 400;\">Bir sistematik derleme yay\u0131mlamayacak olsan\u0131z bile PRISMA ak\u0131\u015f \u015femas\u0131 olu\u015fturun. CER i\u00e7inde tan\u0131mlama, tarama, uygunluk ve dahil etme a\u015famalar\u0131n\u0131 g\u00f6stermenin en temiz yolu bu.<\/p><p style=\"font-weight: 400;\">Her veri taban\u0131 taramas\u0131n\u0131n ham \u00e7\u0131kt\u0131s\u0131n\u0131 zaman damgal\u0131 PDF veya ekran g\u00f6r\u00fcnt\u00fcs\u00fc olarak saklay\u0131n. Onaylanm\u0131\u015f Kurulu\u015f istedi\u011finde sunmas\u0131 en kolay kan\u0131t par\u00e7as\u0131 bu.<\/p><p style=\"font-weight: 400;\">Bir sapma kay\u0131t defteri tutun. Tarama protokol\u00fcn\u00fcz ile ger\u00e7ek taraman\u0131z aras\u0131nda bir \u015fey de\u011fi\u015ftiyse nedenini belgeleyin.<\/p><h2>Kaynak\u00e7a<\/h2><p style=\"font-weight: 400;\">Ecker, E. D., &amp; Skelly, A. C. (2010). Conducting a winning literature search. Evidence-Based Spine-Care Journal, 1(1), 9 to 14.<\/p><p style=\"font-weight: 400;\">European Commission. (2016). MEDDEV 2.7\/1 Revision 4. Clinical Evaluation: A Guide for Manufacturers and Notified Bodies.<\/p><p style=\"font-weight: 400;\">European Parliament and Council. (2017). Regulation (EU) 2017\/745 on Medical Devices (MDR).<\/p><p style=\"font-weight: 400;\">GHTF Study Group 5. (2007). Clinical Evaluation (SG5\/N2R8). Global Harmonization Task Force.<\/p><p style=\"font-weight: 400;\">Pati, D., &amp; Lorusso, L. N. (2017). How to write a systematic review of the literature. Health Environments Research &amp; Design Journal.<\/p><p style=\"font-weight: 400;\">Valla, V., Tzelepi, K., Charitou, P., Lewis, A., Polatidis, B., Koukoura, A., et al. (2023). Use of real-world evidence for international regulatory decision making in medical devices. International Journal of Digital Health, 3(1).<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fc894fd e-flex e-con-boxed e-con e-parent\" data-id=\"fc894fd\" data-element_type=\"container\" data-settings=\"{&quot;ekit_has_onepagescroll_dot&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a18d408 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"a18d408\" data-element_type=\"widget\" data-settings=\"{&quot;ekit_we_effect_on&quot;:&quot;none&quot;}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.bplussolutions.com\/tr\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Request Independent Literature Review Check<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\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>Why this matters If you make medical devices and want to sell them in the EU, you cannot skip the Clinical Evaluation Report (CER). The CER is one of the documents Notified Bodies look at most closely, and the literature search sits at the heart of it. Get this part wrong and you can end [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[19],"tags":[],"class_list":["post-536","post","type-post","status-publish","format-standard","hentry","category-insights"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Literature Search for Clinical Evaluation | Medical Devices Guide<\/title>\n<meta name=\"description\" content=\"Clinical evaluation literature search for medical devices explained. 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