ʻO ka mea i hala koke aku nei, Haiyan Kangyuan MedicalMea hana Ua holo pono ʻo Co., Ltd. i ka ISO13485: 2016 palapala hōʻoia ʻōnaehana hoʻokele maikaʻi.ʻEkolu lā ka loiloi holoʻokoʻa,rʻoliʻoli i ka ʻōnaehana hoʻokele maikaʻi, ka ʻike ʻana a me ka nānā ʻana, nā kuleana hoʻokele, ka loiloi hoʻokele, nā pahuhopu maikaʻi, ka nānā ʻana i ka ʻikepili, nā kumuwaiwai kanaka, nā ʻōnaehana, nā kaʻina pili i nā mea kūʻai aku, ka hoʻolālā a me ka hoʻomohala ʻana, ke kūʻai ʻana, ka hana a me ka hoʻolako lawelawe a me ka hale kūʻai, hoʻokele pilikia, kaʻina hana. hōʻoia, sterilization hōʻoia, traceability, identification kūlana, huahana pale, ka nānā 'ana a me ke ana lako mana, ka mea kūʻai mai hoʻopono Manaʻo (me ka hoʻopiʻi hoʻopiʻi),'ōnaehana hoʻolaha, hoʻokolo kūloko, nonconforming huahana mana, corrective a me ka pale ana, oaoieei palapala loiloi, etc.

This ka loiloi, hōʻoia ʻia e ka hui loiloi ma ka pūnaewele, ua hōʻoia i nā kaʻina hana a pau o ka Kangyuan Medical noiʻi a me ka hoʻomohala ʻana, ka hana ʻana a me ke kūʻai aku e hana ʻia e like me nā ʻōlelo o nā palapala ʻōnaehana hoʻokele maikaʻi, a ua ʻōlelo ʻia e hoʻopuka i kahi palapala.

Ma ke ʻano he ʻōnaehana hoʻokele maikaʻi i ʻike ʻia ma ka honua no ka ʻoihana lāʻau lapaʻau, ua hoʻokuʻu ʻia ka maʻamau hou ISO13485:2016 (pūnaewele hoʻokele maikaʻi o ka lāʻau lapaʻau no nā koi hoʻoponopono) i ka lā Malaki 1, 2016.Hoʻohui ka mana 2016 o ka ISO13485 hou i ka helu nui o nā hana maikaʻi loa o ka ʻoihana lāʻau lapaʻau, kūpono me nā koi o kekahi mau hoʻoponopono lāʻau lapaʻau aupuni, he ʻōnaehana hoʻokele maikaʻi a me ka hoʻopaʻa inoa ʻana a me ka nānā ʻana i nā maʻamau i hui pū ʻia.

Ua hala ʻo Kangyuan Medical i ka palapala hōʻoia no ke kolu o ka manawa, ʻaʻole ia e hōʻike wale i ka ʻike piha ʻana o nā huahana Kangyuan e nā hui kūlana honua, akā e hōʻailona pū ana i ka standardization, standardization a me ka internationalization o Kangyuan medical quality management system.

I kēia manawa, ke lawe nei ʻo Kangyuan Medical i ka US FDA, EU MDR palapala noi a me nā hana ʻē aʻe.Lana ko mākou manaʻo me ke kākoʻo o ka "pass" honua hou aʻe, e uhi ʻo Kangyuan i nā ʻano catheters silicone āpau, nā catheters wela, ka laryngeal mask airway catheter, endoʻūhā ʻūhā, ʻūhāka hoʻoheheʻe ʻana, ʻōpū opu, nā makamaka like ʻole a me nā huahana lāʻau lapaʻau ʻē aʻe i ka honua, e lawelawe ana i nā mea maʻi hou aʻe a puni ka honua, a me ke kōkua ʻana i nā huahana lāʻau lapaʻau e hoʻonui piha ʻia!