Vuba aha, ikoranabuhanga rya Shenzhen Zuowei ryatsinze neza icyemezo cya ISO13485:2016 cy’imicungire y’ubuziranenge bw’ibikoresho by’ubuvuzi, bivuze ko uburyo bw’imicungire y’ubuziranenge bw’ikigo bugeze ku bipimo mpuzamahanga n’ibisabwa n’amategeko.
ISO13485 ni yo mahame mpuzamahanga y’ubuziranenge yemewe cyane mu nganda z’ibikoresho by’ubuvuzi, kandi izina ryayo ryuzuye ry’Igishinwa ni “Uburyo bwo gucunga ubuziranenge bw’ibikoresho by’ubuvuzi ku bisabwa mu mabwiriza”, ikaba ari amahame mpuzamahanga yigenga yashyizweho n’Umuryango Mpuzamahanga wita ku buziranenge (ISO) kandi akoreshwa mu nganda z’ibikoresho by’ubuvuzi. ISO13485 ishingiye kuri ISO9000 kandi yongeraho ibisabwa byihariye ku nganda z’ibikoresho by’ubuvuzi, ari na byo bisabwa cyane mu kumenya ibicuruzwa, kugenzura uburyo bikorerwa n’ibindi bintu.
Shenzhen Zuowei ihora yibanda ku guteza imbere ibicuruzwa, umusaruro no kugenzura ubuziranenge nk'ikintu cy'ingenzi kurusha ibindi, yemeje ko ibicuruzwa by'ikigo cyacu biri mu igenzura ry'ubuziranenge biri mu bipimo mpuzamahanga, kandi igaragaza imbaraga z'ikigo mu guha abakiriya b'ibikoresho by'ubuvuzi ku isi yose serivisi z'ikoranabuhanga n'ibicuruzwa bya tekiniki, kubera iterambere ry'ikigo mu bijyanye n'ibikoresho by'ubuvuzi ryashyizeho umusingi mushya.
Mbere, ibicuruzwa by’ikigo cyacu byatsinze icyemezo cya FDA cyo muri Amerika, icyemezo cya EU MDR ndetse n’icyemezo cya CE. Ibyo byemezo bigaragaza imbaraga z’ubushakashatsi n’iterambere ry’ikigo ndetse n’udushya, uburyo bwiza bw’ibicuruzwa n’imbaraga zacyo zose, bizamura imiterere myiza nk’ubumenyi n’ikoranabuhanga mu ruhando mpuzamahanga!
Mu gihe kizaza, Shenzhen Zuowei izafata iki cyemezo nk'amahirwe, hakurikijwe amahame ngenderwaho y'imicungire y'ubuziranenge, ikomeze gutanga ingwate ishingiye ku micungire inoze, ikomeza kunoza igenzura ry'ubuziranenge imbere, ikomeza kunoza urwego rwa serivisi, kandi itange ibicuruzwa na serivisi nziza ku bakiriya bacu.
Igihe cyo kohereza ubutumwa: Werurwe-17-2023
