Uqeqesho lwe-Hitec Medical MDR – IiMfuno zoXwebhu lobuGcisa phantsi kwe-MDR (Icandelo 1)
| Izinto | Umxholo |
| Inkcazo yesixhobo, ifakwe isoftware kunye nezixhobo | Inkcazo ngokubanzi yemveliso, kubandakanywa ukusetyenziswa ekujoliswe kuyo kunye nabasebenzisi ekujoliswe kubo;UDI;izibonakaliso kunye ne-contraindications;imiyalelo yokusetyenziswa;iimfuno zabasebenzisi;ukuhlelwa kwemveliso;uluhlu lwemodeli;inkcazo yezinto;kunye nezalathi zokusebenza. |
| Ulwazi olunikezelwe ngumenzi | Iileyibhile kwiimveliso kunye nokupakishwa kwazo, imiyalelo yokusetyenziswa.(Sebenzisa ulwimi olwamkelekileyo kwiLizwe loLungu apho isixhobo senzelwe ukuthengiswa) |
| Uyilo kunye nolwazi lokuvelisa | Ulwazi olupheleleyo kunye neenkcukacha zokuqonda isigaba soyilo lwesixhobo, inkqubo yokuvelisa kunye nokuqinisekiswa kwayo, ukubeka iliso okuqhubekayo kunye novavanyo lokugqibela lwemveliso. Chonga indawo apho uyilo kunye nemisebenzi yokuvelisa iya kwenzeka, kubandakanywa iikontraka ezingaphantsi. |
| IiMfuno zoMsebenzi woKhuseleko Jikelele GSPR | Ulwazi lomboniso wokhuseleko jikelele kunye neemfuno zokusebenza kwiSihlomelo I;kubandakanya ukuthetheleleka, ukuqinisekiswa kunye nokuqinisekiswa kwezisombululo ezamkelweyo ukuhlangabezana neemfuno. |
| Uhlalutyo lomngcipheko kunye nolawulo lomngcipheko | Uhlalutyo lwenzuzo yomngcipheko kunye neziphumo zolawulo lomngcipheko zibandakanyiwe kwiSihlomelo I. |
| Ukuqinisekiswa kweMveliso kunye noQinisekiso | Kufuneka iqulathe iziphumo kunye nohlalutyo olubalulekileyo lwazo zonke iimvavanyo zokuqinisekisa kunye nokuqinisekiswa / izifundo ezenziweyo |
Iimfuno zokuleyibhela phantsi kwe-MDR
Ixesha lokuposa: Dec-29-2023