Muva nje, i-Shenzhen Zuowei tech iphumelele ngempumelelo isitifiketi se-ISO13485:2016 sokuphathwa kwekhwalithi yedivayisi yezokwelapha, kusho ukuthi uhlelo lokuphathwa kwekhwalithi yenkampani selufinyelele izindinganiso zamazwe ngamazwe kanye nezidingo zokulawula.
I-ISO 13485 iyindinganiso yekhwalithi yomhlaba wonke egunyazwe kunawo wonke embonini yemishini yezokwelapha, futhi igama layo eliphelele lesiShayina lithi “Uhlelo Lokulawulwa Kwekhwalithi Yedivayisi Yezokwelapha Yezimfuneko Zokulawula”, okuyizinga elizimele lamazwe ngamazwe elakhiwe yi-International Organization for Standardization (ISO) futhi liyasebenza. embonini yemishini yezokwelapha. I-ISO 13485 isuselwe ku-ISO9000 futhi yengeza izimfuneko ezithile ezikhethekile zemboni yemishini yezokwelapha, okuyizidingo eziqinile ekuhlonzeni umkhiqizo, ekulawuleni inqubo nezinye izici.
I-Shenzhen Zuowei ibilokhu igxile ekuthuthukisweni komkhiqizo, ekukhiqizeni nasekulawuleni ikhwalithi njengokuhamba phambili, Iphase i-ISO13485, iphawula ukuthi imikhiqizo yenkampani yethu ekulawuleni ikhwalithi isezingeni lomhlaba, ikhombisa futhi amandla enkampani ukuhlinzeka ngamakhasimende emishini yezokwelapha emhlabeni wonke ngobuchwepheshe. kanye nezinsizakalo zomkhiqizo wezobuchwepheshe, ekuthuthukisweni kwenkampani emkhakheni wemishini yezokwelapha kwabeka isisekelo esisha.
Ngaphambilini, imikhiqizo yenkampani yethu iphase ukubhaliswa kwe-US FDA, ukubhaliswa kwe-EU MDR kanye nesitifiketi se-CE. Lezo zitifiketi ziwukubonakaliswa kwe-R & D yenkampani namandla okuqamba, isistimu yekhwalithi yomkhiqizo namandla aphelele, okuzokhuthaza ngempela ukuma okumangalisayo njengesayensi nobuchwepheshe enkundleni yamazwe ngamazwe!
Ngokuzayo, i-Shenzhen Zuowei izothatha lesi sitifiketi njengethuba, ngokuhambisana ngokuqinile nezindinganiso zesistimu yokuphatha ikhwalithi, iqhubeke nokuqinisekisa ngokusekelwe ekuphatheni okucolisisiwe, ihlale ithuthukisa ukulawulwa kwekhwalithi yangaphakathi, ithuthukisa ngokuqhubekayo amazinga esevisi, futhi ihlinzeka ngemikhiqizo engcono nezinsizakalo zobuchwepheshe. kumakhasimende ethu.
Isikhathi sokuthumela: Mar-17-2023
