Ukuqeqeshwa kwe-Hitec Medical MDR - Izidingo Zokubhaliwe Kwezobuchwepheshe ngaphansi kwe-MDR (Ingxenye 1)
| Izinto | Okuqukethwe |
| Incazelo yedivayisi, isofthiwe efakiwe nezinsiza | Incazelo evamile yomkhiqizo, okuhlanganisa ukusetshenziswa okuhlosiwe kanye nabasebenzisi abahlosiwe;I-UDI;izinkomba kanye contraindications;imiyalelo yokusetshenziswa;izidingo zomsebenzisi;ukuhlukaniswa komkhiqizo;uhlu lwamamodeli;incazelo yezinto ezibonakalayo;kanye nezinkomba zokusebenza. |
| Ulwazi olunikezwe umenzi | Amalebula emikhiqizweni kanye nokupakishwa kwayo, imiyalelo yokusetshenziswa.(Sebenzisa ulimi olwamukelekayo Ezweni Eliyilungu lapho idivayisi ihloselwe ukudayiswa) |
| Ulwazi lokuklama nokukhiqiza | Ulwazi oluphelele kanye nemininingwane yokuqonda isigaba sokuklama socingo, inqubo yokukhiqiza nokuqinisekiswa kwayo, ukuqapha okuqhubekayo kanye nokuhlolwa kokugcina komkhiqizo. Khomba indawo lapho kuzokwenziwa khona imisebenzi yokuklama nokukhiqiza, okuhlanganisa nosonkontileka abancane. |
| Izidingo Zokusebenza Okujwayelekile Kokuphepha GSPR | Ulwazi lokubonisa lwezidingo ezijwayelekile zokuphepha nokusebenza kuSithasiselo I;kuhlanganisa ukulungisiswa, ukuqinisekiswa kanye nokuqinisekiswa kwezixazululo ezamukelwe ukuhlangabezana nezidingo. |
| Ukuhlaziywa kwenzuzo yobungozi kanye nokulawulwa kobungozi | Ukuhlaziywa kwenzuzo yobungozi kanye nemiphumela yokulawulwa kwezinhlekelele kufakwe kuSithasiselo I. |
| Ukuqinisekiswa Komkhiqizo Nokuqinisekiswa | Kufanele iqukathe imiphumela nokuhlaziya okubalulekile kwakho konke ukuqinisekiswa nokuhlolwa kokuqinisekisa/izifundo ezenziwe |
Izidingo zokulebula ngaphansi kwe-MDR
Isikhathi sokuthumela: Dec-29-2023