Kutshanje, Haiyan Kangyuan MedicalIsixhobo Co., Ltd. iphumelele ISO13485:2016 isiqinisekiso senkqubo yolawulo lwesixhobo sonyango.Uphononongo lonke luthatha iintsuku ezintathu,rIchulumancile kwinkqubo yolawulo lomgangatho, ukuchongwa kwenkqubo kunye nohlalutyo, uxanduva lolawulo, uphononongo lolawulo, iinjongo zomgangatho, uhlalutyo lwedatha, izibonelelo zabantu, iziseko zophuhliso, iinkqubo ezinxulumene nabathengi, uyilo kunye nophuhliso, ukuthenga, imveliso kunye nokubonelela ngenkonzo kunye nendawo yokugcina impahla, ulawulo lomngcipheko, ukuqinisekiswa kwenkqubo, ukuqinisekiswa kokuqinisekisa, ukulandelwa, ukuchongwa, ukukhuselwa kwemveliso, ukubeka iliso kunye nolawulo lwezixhobo zokulinganisa, ulwaneliseko lwangaphakathi lomthengi (ukwaneliseka komthengi, ulwaneliseko lwangaphakathi) Ukulawulwa kwemveliso engahambelaniyo, amanyathelo okulungisa kunye nokuthintela, ukuphononongwa koxwebhu lobugcisa, njl.

This uphicotho-zincwadi, oluqinisekiswe liqela lophicotho-zincwadi kwisiza, luqinisekisile ukuba zonke iinkqubo zophando lwezonyango lweKangyuan kunye nophuhliso, ukuveliswa kunye nokuthengisa zenziwa ngokuhambelana nezibonelelo zamaxwebhu enkqubo yolawulo lomgangatho, kwaye kuyacetyiswa ukuba kukhutshwe isatifikethi.

Njengomgangatho wenkqubo yolawulo lomgangatho ovunyiweyo kwihlabathi kushishino lwezixhobo zonyango, umgangatho omtsha we-ISO13485: 2016 (inkqubo yolawulo lomgangatho wesixhobo zonyango kwiimfuno zolawulo) ukhutshwe ngokusesikweni ngomhla woku-1 kuMatshi ngo-2016.Uguqulelo luka-2016 lomgangatho omtsha we-ISO13485 wongeza inani elikhulu lezona ndlela zilungileyo zokwenziwa kwezixhobo zonyango, ezihambelana neemfuno zemithetho yesizwe yesixhobo sonyango, yinkqubo yolawulo lomgangatho kunye nobhaliso lolawulo kunye nolongamelo oludityanisiweyo ngokusondele ngakumbi.

I-Kangyuan Medical iphumelele isiqinisekiso okwesihlandlo sesithathu, esingabonisi kuphela ukuqondwa okubanzi kweemveliso zeKangyuan yimibutho yemigangatho yamazwe ngamazwe, kodwa iphawula umgangatho ongaphezulu, ukulinganisa kunye nokuthengiswa kwamanye amazwe kwenkqubo yolawulo lwezonyango lweKangyuan.

Okwangoku, iKangyuan Medical ikwaqhuba i-US FDA, isicelo sesatifikethi se-EU MDR kunye nomnye umsebenzi.Siyathemba ukuba ngenkxaso ye "pass" engakumbi nangakumbi yehlabathi, iKangyuan iya kugubungela zonke iintlobo ze-silicone catheter, i-catheters yobushushu, i-laryngeal mask airway catheter, endoityhubhu yoqhoqhoqho, ukufunxacatheter, ityhubhu yesisu, iimaski ezahlukeneyo kunye nezinye iimveliso ezinokusetyenziswa kwezonyango kwihlabathi, ukunceda izigulana ezininzi kwihlabathi liphela, kunye nokunceda iimveliso ezisetyenziselwa ukunyanga ziphuculwe ngokupheleleyo!