-
Ukuqeqeshwa kwe-Hitec Medical FDA -Incazelo ye-FDA Yamadivayisi Ezokwelapha - Ingxenye 2
Ukulawula kwe-FDA phezu kwezigaba ezahlukene zemishini yezokwelapha Izidingo zelebula “Ukubhalisa imboni yedivayisi noma ukuthola inombolo yokubhalisa akusho ukugunyazwa okusemthethweni kwefekthri noma imikhiqizo yayo.Noma iyiphi incazelo edala umbono wokuthi ukubhalisa...Funda kabanzi -
Ukuqeqeshwa kwe-Hitec Medical FDA -Incazelo ye-FDA Yamadivayisi Ezokwelapha
Ukuqeqeshwa kwe-Hitec Medical FDA -Incazelo ye-FDA Yamadivayisi Ezokwelapha I-FDA's Definition of Medical Devices Imishini yezokwelapha ibhekisela kumathuluzi, amadivayisi, amathuluzi, imishini, amathuluzi, amashubhu okufaka, ama-in vitro reagent, noma ezinye izinto ezihlobene ezihlangabezana nemibandela elandelayo, okuhlanganisa i-co. .Funda kabanzi -
Ukuqeqeshwa kwe-Hitec Medical FDA - Isingeniso semithetho ye-FDA
Ukuqeqeshwa kwe-Hitec Medical FDA - Isingeniso semithetho ye-FDA Ikhodi Yemithetho Yombuso (CFR) CFR iwukuhlanganiswa kwemithetho evamile nehlala njalo eshicilelwe futhi yanyatheliswa ama-ejensi kahulumeni wobumbano neminyango ku-Federal Register, ngokusebenza kwendawo yonke kanye nomthelela wezomthetho...Funda kabanzi -
IMPILO YASE-ARAB
Kusukela ngoJanuwari 29 kuya kuFebhuwari 1, 2024, umbukiso wama-49 we-Arab Health 2024 International Medical Equipment Exhibition wawubanjelwe ngokusemthethweni eDubai World Trade Center.Ingumbukiso omkhulu wamazwe omhlaba wemishini yezokwelapha esezingeni eliphezulu eMpumalanga Ephakathi, onohlu oluphelele lwemibukiso kanye ne...Funda kabanzi -
2024 Arab Health
Uyemukelwa ukuvakashela i-Hitec Medical eHholo 8 G38, 2024 Dubai Arab Health.U-Hitec ungumkhiqizi ochwepheshe wemikhiqizo yokwelapha yokuphefumula, i-Anesthesia, Urological kanye ne-Infusion.I-Hitec ibhalisiwe ku-ISO13485, i-US FDA isohlwini, futhi izoqinisekiswa nge-MDR CE maduze.Ngethemba eliqotho i-Hitec Medical izoba eyodwa ...Funda kabanzi -
Ukuqeqeshwa kwe-Hitec Medical MDR - Izidingo zemibhalo yezobuchwepheshe ngaphansi kwe-MDR (Ingxenye 2)
Ukuqeqeshwa kwe-Hitec Medical MDR - Izidingo zemibhalo yobuchwepheshe ngaphansi kwe-MDR (Ingxenye 2) Izidingo zokuhlolwa komtholampilo ngaphansi kokuhlolwa komtholampilo kwe-MDR: Ukuhlolwa komtholampilo ukuqoqwa, ukuhlola, nokuhlaziywa kwedatha yomtholampilo ngokusebenzisa indlela eqhubekayo nesebenzayo, kusetshenziswa i-suf...Funda kabanzi -
Ukuqeqeshwa kwe-Hitec Medical MDR - Izidingo Zokubhaliwe Kwezobuchwepheshe ngaphansi kwe-MDR (Ingxenye 2)
Ukuqeqeshwa kwe-Hitec Medical MDR - Izidingo Zemibhalo Yezobuchwepheshe ngaphansi kwe-MDR (Ingxenye 2) Izidingo zokuhlolwa komtholampilo ngaphansi kokuhlolwa komtholampilo kwe-MDR: Ukuhlolwa komtholampilo ukuqoqwa, ukuhlolwa, nokuhlaziywa kwedatha yomtholampilo ngokusebenzisa indlela eqhubekayo nesebenzayo, ukusebenzisa...Funda kabanzi -
Ukuqeqeshwa kwe-Hitec Medical MDR - Izidingo Zokubhaliwe Kwezobuchwepheshe ngaphansi kwe-MDR (Ingxenye 1)
Ukuqeqeshwa kwe-Hitec Medical MDR – Izidingo Zokusebenza Kwemibhalo ngaphansi kwe-MDR (Ingxenye 1) Izingxenye Zokuqukethwe Incazelo yedivayisi, ihlanganisa isofthiwe nezinye izisetshenziswa Incazelo evamile yomkhiqizo, okuhlanganisa ukusetshenziswa okuhlosiwe nabasebenzisi abahlosiwe;I-UDI;izinkomba kanye contraindications;isiyalo...Funda kabanzi -
Ukuqeqeshwa kwe-Hitec Medical MDR - Ukuhlukaniswa komkhiqizo ngaphansi kwe-MDR (Ingxenye 2)
Ukuqeqeshwa kwe-Hitec Medical MDR – Ukuhlukaniswa komkhiqizo ngaphansi kwe-MDR (Ingxenye 2) Umthetho 10. Imishini yokuxilonga neyokuhlola Impahla esetshenziselwa ukukhanyisa (izibani zokuhlola, ama-microscopes okuhlinzwa) Ikilasi I; Ukuze kutholwe ama-radiopharmaceuticals emzimbeni (ikhamera ye-gamma) noma ukuxilongwa okuqondile noma thola...Funda kabanzi -
Ukuqeqeshwa kwe-Hitec Medical MDR - Ukuhlukaniswa komkhiqizo ngaphansi kwe-MDR (Ingxenye 1)
Ukuhlukaniswa komkhiqizo ngaphansi kwe-MDR Ngokusekelwe ekusetshenzisweni okuhlosiwe komkhiqizo, uhlukaniswe ngamazinga amane engozini: I, IIa, IIb, III (Isigaba I singahlukaniswa sibe yi-Is, Im, Ir, ngokuya ngezimo zangempela; lezi zigaba ezintathu nazo zidinga isitifiketi somuntu wesithathu ngaphambi kokuthola isitifiketi se-CE...Funda kabanzi -
Ukuqeqeshwa kwe-Hitec Medical MDR -Incazelo Yemibandela ye-MDR (Ingxenye 2)
Ukuqeqeshwa kwe-Hitec Medical MDR -Incazelo Yemibandela Ye-MDR (Ingxenye 2) Inhloso Yokusetshenziswa Umkhiqizi uchaza ukusetshenziswa ekuhloleni komtholampilo ngokusekelwe kudatha enikezwe kumalebula, imiyalelo, izinto zokukhangisa noma zokuthengisa, noma izitatimende.Lebula umbhalo ophrintiwe noma ulwazi oluyingcaca oluvela o...Funda kabanzi -
Ukuqeqeshwa kwe-Hitec Medical MDR -Incazelo Yemibandela ye-MDR
Ukuqeqeshwa kwe-Hitec Medical MDR – Incazelo ye-MDR Imigomo Yedivayisi Yezokwelapha Ibhekisela kunoma iyiphi insimbi, okokusebenza, into esetshenziswayo, isofthiwe, ukufakelwa, i-reagent, impahla, noma enye into esetshenziswa kuphela noma ihlanganiswe ngumkhiqizi ngenjongo eyodwa noma ngaphezulu ethile yezokwelapha kumuntu. umzimba: Ukuxilongwa, ...Funda kabanzi
