Joytech Medical . Wotsɔ EU ƒe Quality Management System Certificate (MDR) si TüVSüD SÜD na le April 28, 2022 dzi na dzoxɔxɔdzidzenu si wozãna le mɔ̃ dzi, ʋu ƒe sisidzidzenu, infrared to dzoxɔxɔdzidzenu, infrared ŋgonu dzoxɔxɔdzidzenu, multifunction ŋgonu dzoxɔxɔdzidzenu , elektrik no pɔmpi, asi no pɔmpi.Enye dɔwɔƒe gbãtɔ siwo xɔ CE dzi wɔwɔ ƒe ɖaseɖigbalẽ le se yeyea ƒe MDR ƒe nudidiwo te la dometɔ ɖeka, eye wònye MDR ɖaseɖigbalẽ gbãtɔ na aƒeme elektrɔnik dzoxɔxɔdzidzenuwo, tome dzoxɔxɔdzidzenu siwo me dzoxɔxɔ mele o kple no me pɔmpiwo.
Joytech Medical nye atikewɔnuwo dɔwɔƒe si léa fɔ ɖe Numekuku kple Dɔwɔnawo, atikewɔwɔ kple wo dzadzra ŋu hena lãmesẽdzikpɔkpɔ kple dɔléle siwo nɔa anyi didi dzi kpɔkpɔ.Tso esime woɖo dɔwɔƒea la, woda asi ɖe edzi be enye dukɔa ƒe mɔ̃ɖaŋudɔwɔƒe deŋgɔ kple mɔ̃ɖaŋununya deŋgɔ ƒe Numekuku kple Dɔwɔnawo ƒe dɔwɔƒe le Hangzhou.Joytech Medical to ISO13485, MDSAP kple nyonyome dzikpɔkpɔ ƒe ɖoɖo bubuwo me.Míaƒe nuawo xɔ aƒeme NMPA, United States FDA, EU CE, Canada CMDCAS, Japan PMDA kple ɖaseɖigbalẽ bubuwo kple ŋkɔ dede agbalẽ me, eye woda asi ɖe wo dzi be woadzra wo.Eye míeɖo ɣeyiɣi didi ƒe aɖaŋuɖoɖo ƒe nuwɔwɔ aduadu kple dɔwɔƒe xɔŋkɔ geɖe le dukɔa me kple duta.
EU le asi tum ɖo vivivi ɖe asi gã si wɔ ɖeka ŋu be wòaɖe asitsatsa ƒe mɔxenuwo ɖa le dukɔ siwo le eme dome eye wòakpɔ egbɔ be amewo, dɔwɔnawo, ga kple adzɔnuwo (abe atikewɔnuwo ene) nayi faa.Le atikewɔnuwo gome la, Europa Dɔwɔha la to EU ƒe mɔfiame etɔ̃ vɛ be woatsɔ aɖɔli dukɔ ɖesiaɖe ƒe mɔɖeɖedɔa ƒe ɖoɖo gbãtɔ, ale be woate ŋu awɔ ɖeka kple se siwo ku ɖe atike mawo ƒe asitsatsa ŋu.
EU ƒe MDR fia Atikewɔnuwo Ŋuti Sedede (MDR) si dziɖuɖua da asi ɖo si EU ɖe ɖe go (Atikewɔnuwo Ŋuti Sedede (EU) 2017/745), si wotu ɖe MDR ƒe Se 123 lia ƒe nudidiwo dzi.MDR la dze dɔwɔwɔ gɔme le May 26, 2017 dzi eye wòxɔ ɖe Atikewɔnuwo Ŋuti Mɔfiame si nɔ anyi tsã (MDD 93/42/EEC) kple Atikewɔnuwo Ŋuti Mɔfiame si Le Dɔ Wɔm (AEDD) teƒe le se nu tso May 26, 2020 , si nye Atikewɔnuwo Ŋuti Mɔfiame si Woate Ŋu Ade Ame Me (AIMDD 90). /385/EEC) ƒe agbalẽa me.
Ne wotsɔe sɔ kple Atikewɔnuwo ƒe Mɔfiame (MDD) la, MDR la sesẽ wu le adzɔnuwo ƒe afɔku dzi kpɔkpɔ, adzɔnuwo ƒe dɔwɔwɔ kple dedienɔnɔ ƒe dzidzenuwo, dɔdaƒewo ƒe numekuku, kpakple ŋudzɔnɔnɔ le adzɔnuwo ƒe asi megbe kple wo dzi kpɔkpɔ gome.Enye kuxi gã aɖe hã na adzɔnuwɔƒea ƒe nyonyome dzikpɔkpɔ ƒe ɖoɖoa kple adzɔnuwo ƒe dedienɔnɔ ƒe dɔwɔwɔ nyuie.
MDR ƒe ɖaseɖigbalẽ ƒe dzidzedzekpɔkpɔ ɖe Joytech Medical ƒe adzɔnuwo ƒe dzidzenu kɔkɔ kple nyonyome kple EU ƒe asi ƒe dzesidede fia.Joytech Medical atsɔ MDR CE ƒe ɖaseɖigbalẽa abe ŋgɔyiyi ƒe mɔnukpɔkpɔ yeye ene be wòagade to ɖe edzi le xexeame katã ƒe asitsatsa ƒe ɖoɖoa me eye wòakpe asi ɖe xexeame katã ƒe atikewɔwɔ dɔwɔƒea ŋu.
