Vuba aha, Umuganga wa Haiyan KangianIgikoresho Co., Ltd. yatsinze neza Iso13485: 2016 Igikoresho cyo gucunga neza gahunda yo gucunga ubuziranenge.Isubiramo ryose rifata iminsi itatu,rbyishimo kuri sisitemu yo gucunga neza, gutunganya no gusesengura, inshingano zo gucunga, intego zijyanye nubuzima, ibikoresho bijyanye nububiko, imiyoborere, gucunga ibidukikije, inzira Kugenzura, Kugereranya, Kuringaniza, Imiterere iranga, Kurinda ibicuruzwa, Gukoresha ibikoresho byo kuburira, kugenzura ibicuruzwa, Gukosora ibicuruzwa, Isubiramo ryinyandiko za tekiniki, nibindi

This Ubugenzuzi, bugenzurwa n'itsinda ry'ubugenzuzi ku rubuga, yemeje ko inzira zose z'ibitekerezo by'ubuvuzi n'iterambere, umusaruro no kugurisha bikorwa hakurikijwe ibyangombwa bya sisitemu yo gucunga ubuziranenge, kandi birasabwa gutanga icyemezo.

Nka sisitemu yo gucunga ubuziranenge ku rwego mpuzamahanga ku nganda z'ibikoresho by'ubuvuzi, Iso Ridasanzwe Iso1485: 2016 (Sisitemu yo gucunga ubuziranenge bw'ibikoresho byo kugenzura) byarekuwe ku ya 1 Werurwe 2016.Inyandiko ya 2016 ya Iso13485 yongeraho umubare munini wibikoresho byubuvuzi Inganda zubuvuzi, zijyanye nibisabwa namabwiriza yibikoresho byigihugu byigihugu, ni sisitemu yo gucunga ubuziranenge hamwe no kwiyandikisha neza.

Ubuvuzi bwa Kanyuan bwatsinze icyemezo ku nshuro ya gatatu, bidasobanura gusa ibicuruzwa byuzuye ku miryango mpuzamahanga ya Kanyuan n'imiryango mpuzamahanga ishinzwe ibipimo, ariko kandi biranga ibipimo ngenderwaho, imirima n'imiryango itegamiye kuri sisitemu yo gucunga ubwiteganyirize bwa Kangiya.

Kugeza ubu, ubuvuzi bwa Kanyuan nabwo bukora FDA ya FDA, EU MDR impamyabumenyi hamwe nandi kazi.Turizera ko hamwe ninkunga yibindi byinshi byisi yose, Kancuan azatwikira ubwoko bwose bwabatijwe, catheters Catheters, Mask yindege ya Larywal, endoTRACHEAL TUBE, KERAcatheter, umuyoboro wigifu, masks zitandukanye nibindi bikoreshwa nabi kwisi, gukorera abarwayi benshi kwisi, no gufasha amafaranga akoreshwa nabi ibicuruzwa kugirango byumvikane!