Munguva pfupi yapfuura, Shenzhen Zuowei tech yakabudirira kupasa ISO13485: 2016 medical device quality management system certification, zvinoreva kuti hurongwa hwehutano hwekambani hwasvika kune dzimwe nyika nemitemo yemitemo.
ISO13485 ndiyo ine chiremera chepasi rose mhando yemhando muindasitiri yemidziyo yekurapa, uye zita rayo rakazara reChinese ndi "Medical Device Quality Management System for Regulation Requirements", inova chiyero chakazvimirira chepasi rose chakagadzirwa neInternational Organisation for Standardization (ISO) uye chinoshanda. kuindasitiri yemidziyo yekurapa. ISO 13485 yakavakirwa paISO9000 uye inowedzera zvimwe zvakakosha zveindasitiri yemidziyo yekurapa, zvinova zvinodikanwa mukuzivikanwa kwechigadzirwa, kudzora maitiro uye zvimwe zvinhu.
Shenzhen Zuowei yagara yakatarisana nekuvandudzwa kwechigadzirwa, kugadzirwa uye kutonga kwemhando sechinhu chinonyanya kukosha, Yakapfuura ISO13485, ichimaka kuti zvigadzirwa zvekambani yedu mukutonga kwemhando iri mumitemo yepasirese, zvichiratidzazve simba rekambani kupa vatengi vepasi rose michina yekurapa tekinoroji. uye tekinoroji zvigadzirwa masevhisi, ekusimudzira kwekambani mumunda wemidziyo yekurapa yakaisa hwaro hutsva.
Pakutanga, zvigadzirwa zvekambani yedu zvakapfuura iyo US FDA kunyoresa, EU MDR kunyoreswa uye CE certification. Izvo zvitupa chiratidzo chekambani yeR & D uye simba rekuvandudza, chigadzirwa chemhando yehurongwa uye simba rakazara, izvo zvinozosimudzira chimiro chinoshamisa sesainzi uye tekinoroji munhandare yepasirese!
Mune ramangwana, Shenzhen Zuowei achatora chitupa ichi semukana, zvakanyatsoenderana nemhando yekutonga system zviyero, ramba uchivimbisa zvinoenderana nekwakanatswa manejimendi, inogara ichivandudza mukati mehutongi hwemukati, ichiramba ichivandudza masevhisi, uye kupa zvigadzirwa zviri nani uye masevhisi ehunyanzvi. kune vatengi vedu.
Nguva yekutumira: Mar-17-2023
