He mea hoʻohanohano iā mākou ka loaʻa ʻana o ka palapala hōʻoia e ISO 13485.
ʻO kēia palapala hōʻoia e hōʻoia i ka ʻōnaehana hoʻokele maikaʻi o Suzhou Sinomed Co., Ltd.
Pili ka palapala hōʻoia i kēia mau kahua:
Ke kūʻai aku ʻana i nā mea lapaʻau i hoʻomaʻemaʻe ʻole ʻia/sterilized ʻia (nā lako hana laʻana a me nā mea hana, nā paipu alakaʻi kūloko ʻole (plug), nā mea hana ʻoki kino gynecological, nā paipu a me nā masks no ka anesthesia hanu, nā mea hana ʻoki kino neurological a me cardiovascular, nā mea hoʻokomo intravascular, nā ʻaʻahu lapaʻau, nā mea hoʻopau hale hana lapaʻau, nā mea hana waho no nā catheters ʻole vascular, nā mea hana injection a me puncture) a me nā lako hana loiloi parameter physiological a me ke ana (hoʻokuʻu aku i ʻEulopa a me ʻAmelika).
Ua loiloi ʻia a ua hoʻopaʻa inoa ʻia ka Suzhou Sinomed e NQA e like me nā ʻōlelo o ISO 13485: 2016. Aia kēia hoʻopaʻa inoa ʻana ma lalo o ka mālama ʻana o ka ʻoihana i kahi ʻōnaehana hoʻokele maikaʻi, i ke kūlana i luna, ka mea e nānā ʻia e NQA.
E ʻae mākou i nā loiloi nānā mau, e mālama ʻia ka mana o nā palapala hōʻoia no ka hopena maikaʻi o ka loiloi.
Ka manawa hoʻouna: Nov-08-2019
