{"id":1199,"date":"2022-10-05T12:21:15","date_gmt":"2022-10-05T12:21:15","guid":{"rendered":"http:\/\/masacare.com.tr\/?page_id=1199"},"modified":"2022-10-20T08:04:29","modified_gmt":"2022-10-20T08:04:29","slug":"medical-device-technical-files","status":"publish","type":"page","link":"https:\/\/masacare.com.tr\/tr\/medical-device-technical-files\/","title":{"rendered":"T\u0131bbi Cihaz Teknik Dosyalar\u0131"},"content":{"rendered":"
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CE \u0130\u015eARET\u0130<\/h2>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n
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Senin sorular\u0131n var. cevaplar\u0131m\u0131z var.<\/h5>\n <\/div>\n <\/div>\n
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Baz\u0131 mal t\u00fcrleri \u00fczerine konulan bir i\u015farettir ve bu i\u015faretin birbirinden \u00e7ok farkl\u0131 iki anlam\u0131 vard\u0131r. Ana \u00fclkede de \u00fcretim oldu\u011fu i\u00e7in \u00fcr\u00fcnden emin olabilirsiniz. Fransa'da ve Hollanda'da bir \u015firket var. CE i\u015fareti, 1980'lerde Avrupa Toplulu\u011fu taraf\u0131ndan geli\u015ftirilmi\u015ftir ve Avrupa Ortak Pazar\u0131 fikrinin do\u011fdu\u011fu Avrupa Komisyonu veya Avrupa Toplulu\u011funun k\u0131saltmas\u0131d\u0131r.<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n

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\n \n \n GENEL<\/span>\n
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1- M\u00fc\u015fterilerle g\u00f6r\u00fc\u015f\u00fcr ve Modeller, Varyantlar ve Markalar ile birlikte CE \u0130\u015fareti i\u00e7in Cihaz Kapsam\u0131n\u0131 belirler<\/p>\n

2-M\u00fc\u015fterilerin ekip \u00fcyeleriyle EN ISO 13485:2016 Uygulamas\u0131n\u0131 tart\u0131\u015f\u0131r ve haberdar eder.<\/p>\n

3-Organizasyon Yap\u0131s\u0131n\u0131 G\u00f6rev ve Sorumluluklarla D\u00fczenler<\/p>\n

4-Onaylanm\u0131\u015f Kurulu\u015fun belirlenmesine ve MDR\/IVDR Ba\u015fvurusunun yap\u0131lmas\u0131na yard\u0131mc\u0131 olur<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n

\n \n \n Teknik<\/span>\n
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1- \u00dcretici deste\u011fi ile cihaza uygulanabilir \u00fcr\u00fcne \u00f6zel standartlar\u0131, uyumla\u015ft\u0131r\u0131lm\u0131\u015f ve genel standartlar\u0131 belirler.<\/p>\n

2- Tasar\u0131m ve Geli\u015ftirme'den Malzeme Listesi ile birlikte malzemeler, bile\u015fenler, getirilen \u00f6\u011feler, d\u0131\u015f kaynakl\u0131 \u00f6\u011feler, paketleme gereksinimleri \u00f6zellikleri hakk\u0131nda bilgi toplar.<\/p>\n

3- \u00dcretim s\u00fcreci ak\u0131\u015f\u0131, \u00e7evresel ko\u015fullar hakk\u0131nda ayr\u0131nt\u0131lar\u0131 toplar<\/p>\n

4- \u00dcreticinin deste\u011fi ile cihaz paketleme, etiketleme ve nakliye ile ilgili detaylar\u0131 toplar.<\/p>\n

5- Cihaz tan\u0131m\u0131n\u0131, kullan\u0131m amac\u0131n\u0131, kullan\u0131m endikasyonunu, etki mekanizmas\u0131n\u0131 \u00fcreticinin deste\u011fi ile tan\u0131mlar.<\/p>\n

6- \u00dcretici deste\u011fi ile g\u00fcvenlik ve performans gereksinim analizi ve testini destekler.<\/p>\n

7- EN ISO 13485:2016 Dahili GAP De\u011ferlendirmesi\/IQA'y\u0131 ger\u00e7ekle\u015ftirir.<\/p>\n

8- Teknik dok\u00fcmantasyon konsolidasyonu ile i\u00e7 g\u00f6zden ge\u00e7irme ve d\u00fczeltme i\u015flemlerini yapar.<\/p>\n

9- Yerinde KYS & \u00dcr\u00fcn Denetimi yapar ve ard\u0131ndan \u00fcreticinin deste\u011fiyle t\u00fcm bulgular\u0131n kapat\u0131lmas\u0131<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n

\n \n \n Biyolojik De\u011ferlendirme<\/span>\n
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1- G\u00fcvenlik De\u011ferlendirmesi, Biyouyumluluk Testi, Fiziksel karakterizasyon testleri, Kimyasal karakterizasyon testleri, Stabilite \u00e7al\u0131\u015fmalar\u0131, Validasyonlar, Do\u011frulamalar vb. i\u00e7in kaynaklar\u0131 (Dahili\/D\u0131\u015f) tan\u0131mlar.\n\u00fcretici deste\u011fi<\/p>\n

2- Biyolojik de\u011ferlendirme dok\u00fcmantasyon ve testlerinde destekler<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n

\n \n \n Klinik de\u011ferlendirme<\/span>\n
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1- \u00dcreticinin deste\u011fi ile ayn\u0131 risk biyolojik klinik ve teknik e\u015fde\u011ferli\u011fe sahip e\u015fde\u011fer\/benzer cihaz\u0131 tan\u0131mlar.<\/p>\n

2- Avrupa Birli\u011fi'nde veya uluslararas\u0131 pazarlarda bulunan benzer bir cihaz nesli\/jenerasyonu hakk\u0131nda \u00fcretici taraf\u0131ndan verilen ayr\u0131nt\u0131l\u0131 de\u011ferlendirmeyi yapar.<\/p>\n

3- \u00dcretici deste\u011fi ile hasta pop\u00fclasyonunu, klinik durumlar\u0131, kontrendikasyonlar\u0131, uyar\u0131lar\u0131 belirler.<\/p>\n

4- Piyasa Sonras\u0131 G\u00f6zetim ve Periyodik G\u00fcvenlik G\u00fcncelleme Raporu ile birlikte Klinik De\u011ferlendirme Yapar<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n

\n \n \n Fayda-Risk Analizi<\/span>\n
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1- \u00dcreticinin deste\u011fi ile Risk Tan\u0131mlama ve Fayda-Risk Analizi yapar<\/p>\n

2- \u00dcreticinin deste\u011fi ile Risk Y\u00f6netim Plan\u0131 (RMP), Tehlike \u0130zlenebilirlik Matrisi (HTM), Risk Y\u00f6netim Dosyas\u0131 (RMF) vb. Risk Y\u00f6netimi dok\u00fcmanlar\u0131n\u0131 olu\u015fturur.<\/p>\n

3- Risk analizi bo\u015fluklar\u0131n\u0131 belirler ve giderir<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n

\n \n \n Kullan\u0131labilirlik M\u00fchendisli\u011fi<\/span>\n
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1- Kullan\u0131labilirlik M\u00fchendisli\u011fi Dok\u00fcmantasyonunu ger\u00e7ekle\u015ftirir<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n

\n \n \n PAZAR SONRASI KL\u0130N\u0130K TAK\u0130P<\/span>\n
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1- PMS plan\u0131 ve PMS raporu\/PSUR kurulumunda \u00fcreticiye destek olur<\/p>\n

2- Pazar Sonras\u0131 Klinik Takibini (PMCF) ger\u00e7ekle\u015ftirmede \u00fcreticiye destek olur, PMCF plan\u0131n\u0131 ve ilgili raporlar\u0131 belirler<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n

\n \n \n Uygunluk beyan\u0131<\/span>\n
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1- Uygunluk de\u011ferlendirme rotas\u0131n\u0131 belirler ve Uygunluk Beyan\u0131 \u00e7\u0131kar\u0131r.<\/p>\n

2- UDI-DI numaras\u0131, uyumla\u015ft\u0131r\u0131lm\u0131\u015f ve uyumla\u015ft\u0131r\u0131lmam\u0131\u015f standartlar, ortak \u00f6zellikler vb. gibi DOC'a eklenecek ayr\u0131nt\u0131lar konusunda \u00fcretici ile teyit eder.<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"

CE MARKING You have questions. wE have answers. It is a mark placed on some types of goods, and this mark has two very different meanings. You can be sure of the product as there is also a manufacture in the mother country. There is a company in France and in Holland. The CE mark […]<\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-templates\/full-width-page.php","meta":{"footnotes":""},"class_list":["post-1199","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/pages\/1199","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/comments?post=1199"}],"version-history":[{"count":15,"href":"https:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/pages\/1199\/revisions"}],"predecessor-version":[{"id":1626,"href":"https:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/pages\/1199\/revisions\/1626"}],"wp:attachment":[{"href":"https:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/media?parent=1199"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}