Muva nje, uHaiyan Kangyuan MedicalInto yokwenza utho I-Co, Ltd idluliselwe ngempumelelo i-ISO13485: Isitifiketi Sohlelo Lwezimo Zedivayisi yango-2016.Ukubuyekezwa konke kuthatha izinsuku ezintathu,riye yandiswa ohlelweni lokuphathwa kwekhwalithi, ukucubungulwa kwenqubo kanye nokuhlaziywa, imithwalo yemfanelo yokuphatha, izibuyekezo zekhwalithi, izinqubo zabantu, ukuklanywa kanye nokukhiqizwa kwezinsizakalo kanye nokugcinwa kwezezimali, inqubo yengozi, inqubo Ukuqinisekiswa, ukuqinisekiswa kwe-inzalo, isimo sokukhonjwa, isimo sokukhonjwa, ukuvikelwa komkhiqizo, ukuphathwa kwemishini yokulinganisa, Impendulo Yokuqothula Yamakhasimende (Ukuhlolwa Kwangaphakathi, Ukulawulwa Komkhiqizo, Ukuvuselelwa Kwemikhiqizo Yezobuchwepheshe, njll.

This Ukucwaningwa kwamabhuku, kuqinisekiswe yiqembu lokucwaningwa kwamabhuku esizeni, kuqinisekisile ukuthi zonke izinqubo zocwaningo lwe-kangyuan Medical and Development, ukukhiqizwa kanye nokuthengisa kwenziwa ngokuhambisana nezinhlinzeko zohlelo lokuphathwa kwekhwalithi, futhi kunconywa ukukhipha isitifiketi.

Njengesistimu yohlelo lokuphathwa kwekhwalithi yomhlaba wonke embonini yedivayisi yezokwelapha, i-ISO1348488 entsha entsha: 2016 (Uhlelo Lokulawulwa Kwekhwalithi yezokwelapha lwezidingo zokulawula) lukhishwe ngokusemthethweni ngoMashi 1, 2016.I-2016 version ye-ISO13488S Standard entsha yenezela inani elikhulu lemikhakha yedivayisi yezokwelapha, iyahambisana nezidingo zeNational Nemit Medical Reganes, uhlelo lokuphathwa kwekhwalithi kanye nokugadwa okuhlanganisiwe okuhlanganisiwe.

I-Kangyuan Medical idlulise isitifiketi sesithathu, esingakhombisa kuphela ukuqashelwa okuphelele kwemikhiqizo yaseKangyuan yizinhlangano zamazinga ezwe lonke, kepha futhi zimaka ngokwengeziwe, okwenziwe ngokwejwayelekile kanye nohlelo lwe-Kangyuan Medical Management System.

Njengamanje, iKangyuan Medical inenza ne-FDA ye-US FDA, isicelo sesitifiketi se-EU kanye nomsebenzi.Siyethemba ukuthi ngokwesekwa "Pass" Okusemhlabeni wonke jikelele, iKangyuan izohlanganisa zonke izinhlobo zama-Silicone Catheters, ama-laryngeal mask catheter catheter, nikaishubhu le-tracheal, ukumuncaunciphe, ishubhu lesisu, imaski ehlukahlukene kanye neminye imikhiqizo yokudla yezokwelapha emhlabeni, esebenza iziguli eziningi emhlabeni jikelele, futhi kusiza imikhiqizo yokudla yezokwelapha ukuthi ithuthukiswe ngokuphelele!