Vuba aha, tekinoroji ya Shenzhen Zuowei yatsinze neza ISO13485: 2016 ibyemezo byubuvuzi bwa sisitemu yubuvuzi bwiza, bivuze ko sisitemu yo gucunga ubuziranenge bwikigo igeze ku rwego mpuzamahanga nibisabwa n'amategeko.
ISO13485 nicyo cyemezo mpuzamahanga cyemewe cya sisitemu yubuziranenge mu nganda zikoreshwa mu buvuzi, kandi izina ryayo ryuzuye ry’igishinwa ni “Ubuvuzi bw’ibikoresho by’ubuvuzi bwo kugenzura ibyangombwa bisabwa”, akaba ari amahame mpuzamahanga yigenga yashyizweho n’umuryango mpuzamahanga wita ku bipimo ngenderwaho (ISO) kandi birashoboka ku nganda zikoreshwa mu buvuzi. ISO13485 ishingiye kuri ISO9000 kandi ikongeramo bimwe byihariye bisabwa mubikoresho byubuvuzi, ibyo bikaba bisabwa cyane mukumenyekanisha ibicuruzwa, kugenzura inzira nibindi.
Shenzhen Zuowei yamye yibanda mugutezimbere ibicuruzwa, kubyaza umusaruro no kugenzura ubuziranenge nkibyingenzi byambere, Yatsinze ISO13485, agaragaza ko ibicuruzwa byikigo cyacu mugucunga ubuziranenge biri mubipimo mpuzamahanga, bikomeza kwerekana imbaraga zuruganda rwo guha abakiriya ibikoresho byubuvuzi kwisi yose hamwe nikoranabuhanga na serivisi zicuruzwa tekinike, kugirango iterambere ryikigo mubijyanye nubuvuzi ryashizeho urufatiro rushya.
Mbere, ibicuruzwa byisosiyete yacu byatsinze Amerika FDA kwiyandikisha, EU MDR kwiyandikisha hamwe na CE. Izo mpamyabumenyi zigaragaza R & D hamwe nimbaraga zo guhanga udushya, sisitemu yubuziranenge bwibicuruzwa n'imbaraga zuzuye, byanze bikunze bizamura imyifatire myiza nka siyanse n'ikoranabuhanga mu ruhando mpuzamahanga!
Mu bihe biri imbere, Shenzhen Zuowei azafata iki cyemezo nk'akanya, akurikije byimazeyo ibipimo ngenderwaho bya sisitemu yo gucunga ubuziranenge, akomeze gutanga ingwate ashingiye ku micungire inoze, guhora atezimbere igenzura ry'imbere mu gihugu, guhora atezimbere urwego rwa serivisi, kandi atange ibicuruzwa byiza na serivisi za tekiniki. kubakiriya bacu.
Igihe cyo kohereza: Werurwe-17-2023
