I kēia mau lā i hala koke aku nei, ua holomua ʻo Shenzhen Zuowei tech i ka palapala hōʻoia ʻōnaehana hoʻokele maikaʻi o nā hāmeʻa lapaʻau ISO13485:2016, ʻo ia hoʻi ua hoʻokō ka ʻōnaehana hoʻokele maikaʻi o ka hui i nā kūlana honua a me nā koi hoʻoponopono.
ʻO ISO13485 ka maʻamau ʻōnaehana kūlana honua i mana loa ʻia ma ka ʻoihana hāmeʻa lapaʻau, a ʻo kona inoa piha Kina ʻo "Medical Device Quality Management System for Regulation Requirements", he maʻamau honua kūʻokoʻa i hoʻomohala ʻia e ka International Organization for Standardization (ISO) a pili i ka ʻoihana hāmeʻa lapaʻau. Hoʻokumu ʻia ʻo ISO13485 ma ISO9000 a hoʻohui i kekahi mau koi kūikawā no ka ʻoihana hāmeʻa lapaʻau, ʻo ia hoʻi nā koi koʻikoʻi i ka ʻike huahana, ka kaohi kaʻina hana a me nā ʻano ʻē aʻe.
Ua kālele mau ʻo Shenzhen Zuowei i ka hoʻomohala huahana, ka hana ʻana a me ka kaohi maikaʻi ma ke ʻano he mea nui loa, Ua hala ka ISO13485, e hōʻailona ana i ka hoʻokō ʻana o nā huahana o kā mākou hui i nā kūlana honua, e hōʻike hou ana i ka ikaika o ka hui e hāʻawi i nā mea kūʻai aku i nā mea lapaʻau honua me ka ʻenehana a me nā lawelawe huahana loea, no ka hoʻomohala ʻana o ka hui ma ke kahua o nā mea lapaʻau ua hoʻokumu i kahi kahua hou.
Ma mua, ua hala nā huahana a kā mākou hui i ka palapala hoʻopaʻa inoa US FDA, ka palapala hoʻopaʻa inoa EU MDR a me ka palapala hōʻoia CE. ʻO kēlā mau palapala hōʻoia he hōʻike ia o ka ikaika R&D a me ka hana hou o ka hui, ka ʻōnaehana maikaʻi huahana a me ka ikaika piha, ka mea e hoʻolaha maoli i kahi kūlana kupaianaha ma ke ʻano he ʻepekema a me ka ʻenehana ma ke kahua honua!
I ka wā e hiki mai ana, e lawe ʻo Shenzhen Zuowei i kēia palapala hōʻoia ma ke ʻano he manawa kūpono, e kūlike me nā kūlana ʻōnaehana hoʻokele maikaʻi, e hoʻomau i ka hōʻoia e pili ana i ka hoʻokele maikaʻi ʻana, e hoʻomaikaʻi mau i ka kaohi maikaʻi kūloko, e hoʻomaikaʻi mau i nā pae lawelawe, a hāʻawi i nā huahana a me nā lawelawe loea maikaʻi aʻe no kā mākou mea kūʻai aku.
Ka manawa hoʻouna: Malaki-17-2023
