Talu ai nei, Haiyan Kangyuan MedicalMeafaigaluega Co., Ltd. manuia pasia ISO13485:2016 masini faafomai tulaga lelei pulega tusi faamaonia.O le iloiloga atoa e tolu aso,rfiafia i faiga pulega lelei, faʻamatalaga faʻagasologa ma auʻiliʻiliga, matafaioi tau pulega, iloiloga o le pulega, sini lelei, auʻiliʻiliga o faʻamaumauga, tagata faigaluega, atinaʻe, faʻagasologa o tagata faʻatau, mamanu ma atinaʻe, faʻatauga, gaosiga ma le tuʻuina atu o auaunaga ma fale teu oloa, pulega lamatia, faagasologa faʻamaoniga, faʻamaonia faʻamaonia, suʻesuʻeina, tulaga faʻamaonia, puipuiga o oloa, mataʻituina ma le fuaina o meafaigaluega, faʻamalieina o tagata faʻatau Manatu (e aofia ai le taulimaina o faitioga), faiga lapatai, suʻega faʻalotoifale, le faʻaogaina o oloa, faʻasaʻo ma le puipuiga, iloiloga o pepa faʻapitoa, ma isi.

This su'etusi, fa'amaonia e le au su'etusi i luga o le 'upega tafa'ilagi, fa'amaonia o fa'agasologa uma o su'esu'ega Fa'afoma'i a Kangyuan ma atina'e, gaosiga ma fa'atauga o lo'o fa'atinoina e tusa ai ma aiaiga o le faiga o le pulega lelei pepa, ma e fautuaina e tu'uina atu se tusi faamaonia.

I le avea ai o se tulaga faʻavaomalo faʻapitoa mo pulega faʻapitoa mo le falemaʻi masini faʻafomaʻi, o le ISO13485: 2016 (faʻatonuga faʻapitoa mo masini faʻafomaʻi mo manaʻoga faʻatonutonu) ua faʻasalalau aloaia i le aso 1 o Mati, 2016.O le 2016 version of the new ISO13485 standard e faʻaopoopoina ai le tele o faʻataʻitaʻiga faʻapitoa tau masini faʻafomaʻi, e fetaui ma manaʻoga o nisi o tulafono faʻalesoifua maloloina a le atunuʻu, o se faiga faʻaleleia lelei ma le resitalaina ma le vaavaaiga sili atu ona tuʻufaʻatasia tuʻufaʻatasia.

Kangyuan Medical na pasia le tusipasi mo le taimi lona tolu, lea e le gata ina atagia ai le aloaia atoatoa o oloa Kangyuan e faʻalapotopotoga faʻavaomalo faʻavaomalo, ae o loʻo faʻailogaina foʻi le faʻasalalauga atili, faʻasalalauga ma le faʻavaomaloina o le pulega lelei o le pulega faafomaʻi Kangyuan.

I le taimi nei, o loʻo faʻatinoina foi e le Kangyuan Medical le US FDA, EU MDR faʻamaonia talosaga ma isi galuega.Matou te faʻamoemoe o le lagolago a le tele ma le tele o le lalolagi "pasi", Kangyuan o le a ufiufi uma ituaiga o faʻamaʻi silikoni, vevela vevela, laryngeal mask airway catheter, fa'ai'ugafa'apa'u fa'asusu, fa'asusucatheter, manava manava, ufimata eseese ma isi oloa faʻaaogaina faʻafomaʻi i le lalolagi, tautuaina le tele o gasegase i le lalolagi atoa, ma fesoasoani i oloa faʻaaogaina faʻafomaʻi ina ia faʻaleleia atoatoa!