Huamei Laser, inotungamira mugadziri wemidziyo yelaser, inosimbisa kuzvipira kwayo kusimbisiro yemhando uye kutevedzera zviyero zvepasirese nekukasira kugadzirisa yayo Medical Device Directive (MDD) kune itsva Medical Device Regulation (MDR). Iyi nhanho inosimbisa kuzvipira kwekambani kuzadzisa zvinodiwa zvekutonga uye kuve nechokwadi chepamusoro miitiro yekuchengetedza uye kushanda kune zvigadzirwa zvayo.
Shanduko kubva kuMDD kuenda kuMDR inoreva shanduko yakakosha yemitemo yemidziyo yekurapa mukati meEuropean Union. Nekuvandudza kuMDR, Huamei Laser inova nechokwadi chekuti michina yayo yelaser inosangana neazvino zviyero uye zvakatemwa neEU mirau. Iyi proactive maitiro haingoratidzi kuchinjika kwekambani chete asiwo inowedzera chivimbo pakati pevatengi nevatori vechikamu maererano nemhando nekuchengetedzeka kwezvigadzirwa zvayo.
"Kuve nechokwadi chekutevedzera zvigadziriso zvemitemo kwakakosha kwatiri," akadaro David, Boss kuHuamei Laser. "Nekuchinja kuenda kuMDR nenguva, tinosimudzira kuzvipira kwedu kuendesa yakachengeteka uye inoshanda laser michina inosangana nemhando yepamusoro yemhando uye kuita."
Pamusoro pekugadzirisa MDD yayo kuMDR, Huamei Laser iri zvakare mubishi rekunyorera iyo Medical Device Single Audit Program (MDSAP) certification. Iyo MDSAP certification inocherechedzwa nevakawanda vane masimba, kusanganisira avo vari kuAustralia, Brazil, Canada, Japan, uye United States. Nekuwana MDSAP certification, Huamei Laser ine chinangwa chekuwedzera kusimbisa kuedza kwayo kwekuteerera uye kutsigira zvido zvevanogovera mumisika iyi yakakosha.
"Kutsvaga chitupa cheMDSAP kunoenderana nehurongwa hwedu hwekupa vanogovera pasi rose magwaro anodiwa ekupinza uye kugovera zvigadzirwa zvedu," akawedzera David. "Ichi chitupa hachingogadzirise maitiro ekutonga chete asiwo kusimudzira hukama hwedu nevashambadzi, kuve nechokwadi chekubudirira pamwe nekuenderera mberi nekukura."
Huamei Laser's proactive approach to regulatory competing inosimbisa kuzvipira kwayo kusingazununguki kune mhando uye chengetedzo mukati memhando yechigadzirwa. Nekugara ichiziva nezvezvigadziriso zvemitemo uye kuwana zvitupa zvakakodzera, kambani inosimbisa chinzvimbo chayo semupi akavimbika wemidziyo yelaser pasi rese.
Nguva yekutumira: Kubvumbi-23-2024