Sivuyisana nawe!I-Shenzhen Zuowei Tech iphumelele ngempumelelo inkqubo yolawulo lomgangatho we-ISO13485 yamazwe ngamazwe.

Kutshanje, i-Shenzhen Zuowei tech iphumelele ngempumelelo i-ISO13485: isiqinisekiso senkqubo yolawulo lwesixhobo sonyango se-2016, oko kuthetha ukuba inkqubo yolawulo lomgangatho wenkampani ifikelele kwimigangatho yamazwe ngamazwe kunye neemfuno zolawulo.

I-ISO 13485 ngowona mgangatho ugunyazisiweyo wenkqubo yomgangatho wehlabathi kushishino lwezixhobo zonyango, kwaye igama layo elipheleleyo lesiTshayina lithi “INkqubo yoLawulo loMgangatho weSixhobo seMedical yeeMfuneko zoLawulo”, ngumgangatho ozimeleyo wezizwe ngezizwe ophuhliswe nguMbutho weZizwe ngezizwe wokuMiselwa (ISO) kwaye uyasebenza. kushishino lwezixhobo zonyango.I-ISO 13485 isekwe kwi-ISO9000 kwaye yongeza iimfuno ezikhethekileyo kushishino lwezixhobo zonyango, eziziimfuno ezingqongqo ekuchongeni imveliso, ulawulo lwenkqubo kunye neminye imiba.

I-Shenzhen Zuowei isoloko igxininise kuphuhliso lwemveliso, imveliso kunye nolawulo lomgangatho njengento ephambili ephambili, Yadlula i-ISO13485, iphawula ukuba iimveliso zenkampani yethu ekulawuleni umgangatho zikwimigangatho yamazwe ngamazwe, zibonisa ngakumbi amandla enkampani ukubonelela abathengi bezixhobo zonyango zehlabathi ngeteknoloji. kunye neenkonzo zemveliso yobugcisa, uphuhliso lwenkampani kwinkalo yezixhobo zonyango lwabeka isiseko esitsha.

Ngaphambili, iimveliso zenkampani yethu zigqithise ukubhaliswa kwe-FDA yase-US, ukubhaliswa kwe-EU MDR kunye nesiqinisekiso se-CE.Ezo zatifikethi ziyimbonakaliso yeR & D yenkampani kunye namandla okuvelisa, inkqubo yomgangatho wemveliso kunye namandla abanzi, aya kuthi ngokuqinisekileyo akhuthaze ukuma okumangalisayo njengesayensi kunye netekhnoloji kwibala lamazwe ngamazwe!

Kwixesha elizayo, i-Shenzhen Zuowei iya kuthatha esi satifikethi njengethuba, ngokungqongqo ngokuhambelana nemigangatho yenkqubo yokulawula umgangatho, ukuqhubeka nokuqinisekisa okusekelwe kulawulo olusulungekileyo, ukuphucula rhoqo ulawulo lwangaphakathi, ukuphucula ngokuqhubekayo amanqanaba eenkonzo, kunye nokubonelela ngeemveliso ezingcono kunye neenkonzo zobugcisa. kubathengi bethu.