He honore nui ki a mātou te whiwhi i te tiwhikete ISO 13485.
Hei whakamana tēnei tiwhikete ko te Pūnaha Whakahaere Kounga o Suzhou Sinomed Co., Ltd.
E pā ana te tiwhikete ki ēnei mara:
Te hoko i ngā taputapu hauora kāore i te parakore/kua parakore (ngā taputapu me ngā taputapu tango tauira, ngā ngongo arataki ā-roto kāore i te whai toto, ngā taputapu pokanga wahine, ngā ngongo me ngā kopare mō te whakamoe manawa, ngā taputapu pokanga neurological me te cardiovascular, ngā taputapu werohanga ā-roto, ngā takai hauora, ngā taputapu taiwhanga hauora, ngā taputapu o waho mō ngā catheter kāore i te whai toto, ngā taputapu werohanga me te poka) me ngā taputapu tātari me te ine tawhā ā-tinana (kaweake ki Ūropi me Amerika).
Kua aromatawaitia, kua rēhitatia hoki te Suzhou Sinomed e te NQA i runga anō i ngā whakaritenga o te ISO 13485: 2016. Kei raro i tēnei rēhitatanga te kamupene e pupuri ana i tētahi pūnaha whakahaere kounga, e ai ki te paerewa i runga ake nei, ā, ka aroturukitia e te NQA.
Ka whakaaetia e mātou ngā aromatawai tirotiro auau, me pupuri tonu te mana o ngā tiwhikete kia pai ai te hua o te arotake.
Wā tuku: Whiringa-ā-rangi-08-2019
