Munguva pfupi yapfuura, Haiyan Kangyuan MedicalChimbo Co., Ltd. yakabudirira kupasa ISO13485:2016 yezvokurapa mudziyo wemhando yekutarisira system certification.Kuongorora kwese kunotora mazuva matatu,rinonakidzwa nehurongwa hwekutonga kwemhando, kucherechedzwa kwemaitiro uye kuongorora, mabasa ekutonga, ongororo yehutungamiriri, zvinangwa zvemhando, kuongororwa kwedata, zviwanikwa zvevanhu, zvivakwa, maitiro ane chekuita nevatengi, dhizaini nekusimudzira, kutenga, kugadzira uye kupihwa kwesevhisi uye dura, manejimendi enjodzi, maitiro. verification, sterilization verification, traceability, chiziviso chimiro, kuchengetedzwa kwechigadzirwa, kutarisisa uye kuyerwa kwemidziyo kudzora, kugutsikana kwevatengi Feedback (kusanganisira kubata zvichemo), yambiro sisitimu, kuongorora kwemukati, kusaenderana kwechigadzirwa kutonga, kugadzirisa uye kudzivirira matanho, hunyanzvi gwaro rekuongorora, nezvimwe.

This odhita, yakasimbiswa neboka rekuongorora pasaiti, yakasimbisa kuti maitiro ese eKangyuan Medical tsvagiridzo nekusimudzira, kugadzirwa uye kutengesa kunoitwa zvinoenderana nezvinopihwa zvemhando yepamusoro magwaro ehurongwa hwekutonga, uye zvinokurudzirwa kuburitsa chitupa.

Seyakajairwa pasi rose yemhando yehutongi hwemhando yeindasitiri yezvishandiso zvekurapa, chiyero chitsva ISO13485:2016 (medical device quality management system yezvinodiwa zvemitemo) yakaburitswa zviri pamutemo munaKurume 1, 2016.Iyo 2016 vhezheni yeiyo itsva ISO13485 chiyero inowedzera huwandu hukuru hweindasitiri yemidziyo yekurapa maitiro akanakisa, anoenderana nezvinodiwa zvemimwe mitemo yenyika yezvishandiso zvekurapa, ihurongwa hwehutongi hwemhando uye kunyoreswa kwemitemo uye kutarisisa kwakanyatso kubatanidzwa zviyero.

Kangyuan Medical akapasa chitupa kechitatu, izvo zvisingangoratidzi kucherechedzwa kwakazara kweKangyuan zvigadzirwa nemasangano epasi rose, asi zvakare inoratidza kumwe kumisa, kuenzanisa uye kudyidzana nedzimwe nyika kweKangyuan kurapwa kwemhando yehutano system.

Parizvino, Kangyuan Medical iri kuitawo US FDA, EU MDR certification application uye rimwe basa.Tinovimba kuti nerutsigiro rwepasi rose "pass", Kangyuan ichavhara marudzi ese esilicone catheter, tembiricha catheter, laryngeal mask airway catheter, endotracheal chubhu, kuyamwacatheter, machubhu emudumbu, masiki akasiyana siyana uye zvimwe zvigadzirwa zvekurapa zvepasirese, kushandira varwere vakawanda pasirese, uye kubatsira zvigadzirwa zvemishonga kuti zvikwidziridzwe zvizere!