Nō nā tata nei, i angitu a Shenzhen Zuowei tech i te tiwhikete pūnaha whakahaere kounga taputapu hauora ISO13485:2016, ko te tikanga kua eke te pūnaha whakahaere kounga a te kamupene ki ngā paerewa o te ao me ngā whakaritenga ture.
Ko te ISO13485 te paerewa pūnaha kounga o te ao tino mana i roto i te umanga taputapu hauora, ā, ko tōna ingoa Hainamana katoa ko "Medical Device Quality Management System for Regulation Requirements", he paerewa o te ao motuhake i whakawhanakehia e te International Organization for Standardization (ISO) ā, e tika ana mō te umanga taputapu hauora. Ko te ISO13485 e hangai ana ki te ISO9000 me te tāpiri i ētahi whakaritenga motuhake mō te umanga taputapu hauora, arā, he whakaritenga tino pakari mō te tautuhi hua, te whakahaere tukanga me ētahi atu āhuatanga.
Kua arotahi tonu a Shenzhen Zuowei ki te whanaketanga hua, te whakaputa me te whakahaere kounga hei kaupapa matua. Kua paahitia e ia te ISO13485, e tohu ana kei roto i ngā paerewa o te ao ngā hua o tā mātou kamupene i roto i te mana whakahaere kounga, e whakaatu ana i te kaha o te kamupene ki te whakarato hangarau me ngā ratonga hua hangarau ki ngā kiritaki taputapu hauora o te ao. Nā te whanaketanga o te kamupene i roto i te mara o ngā taputapu hauora i whakatakoto he turanga hou.
I mua, kua paahitia e ngā hua a tā mātou kamupene te rēhitatanga FDA o Amerika, te rēhitatanga MDR o EU me te tiwhikete CE. Ko aua tiwhikete he whakaata i te kaha o te R&D me te auahatanga, te pūnaha kounga hua me te kaha whānui, e tino whakatairanga ana i tētahi tūnga whakamiharo ake hei pūtaiao me te hangarau i te ao whānui!
I te heke mai, ka whakamahia e Shenzhen Zuowei tēnei tiwhikete hei whai wāhitanga, kia rite tonu ki ngā paerewa pūnaha whakahaere kounga, kia mau tonu te whakamana i runga i te whakahaere kua whakatikatikaina, kia whakapai tonu i te mana whakahaere kounga ā-roto, kia whakapai tonu i ngā taumata ratonga, me te whakarato hua me ngā ratonga hangarau pai ake mō ā mātou kiritaki.
Wā tuku: Maehe-17-2023
