Halala! I-Shenzhen Zuowei Tech iphumelele ngempumelelo isitifiketi sokuphathwa kwekhwalithi se-ISO13485 samazwe ngamazwe.

Muva nje, ubuchwepheshe beShenzhen Zuowei buphumelele ukuphumelela isitifiketi sokuphathwa kwekhwalithi yedivayisi yezokwelapha i-ISO13485:2016, okusho ukuthi uhlelo lokuphathwa kwekhwalithi yenkampani selufinyelele amazinga omhlaba kanye nezimfuneko zomthetho.

I-ISO13485 iyindinganiso yesistimu yekhwalithi yamazwe ngamazwe enegunya elikhulu embonini yamadivayisi ezokwelapha, futhi igama layo eliphelele lesiShayina lithi “Uhlelo Lokuphathwa Kwekhwalithi Yamadivayisi Ezokwelapha Lwezidingo Zomthethonqubo”, okuyindinganiso yamazwe ngamazwe ezimele eyakhiwe yi-International Organisation for Standardization (ISO) futhi esebenza embonini yamadivayisi ezokwelapha. I-ISO13485 isekelwe ku-ISO9000 futhi yengeza ezinye izidingo ezikhethekile embonini yamadivayisi ezokwelapha, okuyizidingo eziqinile ekuhlonzeni umkhiqizo, ekulawuleni inqubo nezinye izici.

I-Shenzhen Zuowei ibilokhu igxile ekuthuthukisweni komkhiqizo, ekukhiqizweni nasekulawulweni kwekhwalithi njengento eza kuqala, idlulise i-ISO13485, iphawula ukuthi imikhiqizo yenkampani yethu ekulawulweni kwekhwalithi isezindinganisweni zomhlaba wonke, iqhubeka nokukhombisa amandla enkampani okuhlinzeka amakhasimende edivayisi yezokwelapha emhlabeni wonke ngobuchwepheshe kanye nezinsizakalo zomkhiqizo wezobuchwepheshe, ngoba intuthuko yenkampani emkhakheni wamadivayisi ezokwelapha yabeka isisekelo esisha.

Ngaphambilini, imikhiqizo yenkampani yethu iphumelele ukubhaliswa kwe-US FDA, ukubhaliswa kwe-EU MDR kanye nesitifiketi se-CE. Lezo zitifiketi ziwukubonakaliswa kwamandla enkampani e-R&D kanye nokusungula izinto ezintsha, uhlelo lwekhwalithi yomkhiqizo kanye namandla aphelele, okuzoqinisekisa ngokuqinisekile ukuma okuhle kakhulu njengesayensi nobuchwepheshe emkhakheni wamazwe ngamazwe!

Esikhathini esizayo, iShenzhen Zuowei izothatha lesi sitifiketi njengethuba, ngokuhambisana ngokuqinile nezindinganiso zohlelo lokuphathwa kwekhwalithi, iqhubeke nokuqinisekisa ngokusekelwe ekuphathweni okucwengekile, ithuthukise njalo ukulawulwa kwekhwalithi yangaphakathi, ithuthukise amazinga esevisi njalo, futhi inikeze imikhiqizo nezinsizakalo zobuchwepheshe ezingcono kumakhasimende ethu.