Joytech Medical tau txais daim ntawv pov thawj EU Quality Management System Certificate (MDR) muab los ntawm TüVSüD SÜD thaum lub Plaub Hlis 28, 2022. Cov peev txheej ntawm cov ntawv pov thawj suav nrog: digital thermometer, ntshav siab saib xyuas, infrared pob ntseg tus pas ntsuas kub, infrared forehead tus pas ntsuas kub, multifunction hauv pliaj tus pas ntsuas kub , hluav taws xob lub mis twj tso kua mis, phau ntawv lub mis twj tso kua mis.Nws yog ib lub tuam txhab ntxov tshaj plaws hauv Suav teb kom tau txais daim ntawv pov thawj CE raws li txoj cai tshiab MDR cov cai, thiab yog thawj daim ntawv pov thawj MDR rau cov ntsuas hluav taws xob hauv tsev, cov ntsuas kub hauv lub pob ntseg thiab cov twj tso kua mis.
Joytech Medical yog ib lub tuam txhab kho mob uas tsom mus rau R&D, kev tsim khoom thiab muag khoom siv kho mob rau kev saib xyuas kev noj qab haus huv thiab kev tswj hwm kab mob ntev.Txij li thaum nws tsim, lub tuam txhab tau lees paub tias yog lub teb chaws high-tech enterprise thiab high-tech R & D center enterprise nyob rau hauv Hangzhou.Joytech Medical tau dhau ISO13485, MDSAP thiab lwm yam kev tswj xyuas zoo.Peb cov khoom tau txais NMPA, US FDA, EU CE, Canada CMDCAS, Nyiv PMDA thiab lwm yam ntawv pov thawj thiab kev sau npe, thiab tau txais kev pom zoo rau kev lag luam.Thiab peb tau mus txog lub sijhawm ntev kev koom tes nrog ntau lub tuam txhab nto moo hauv tsev thiab txawv teb chaws.
EU tab tom tsim kom muaj kev sib koom ua lag luam loj los tshem tawm cov kev cuam tshuam kev lag luam ntawm cov tswv cuab hauv lub xeev thiab xyuas kom muaj kev ywj pheej ntawm tib neeg, kev pabcuam, peev thiab cov khoom lag luam (xws li cov khoom siv kho mob).Hauv kev ua haujlwm ntawm cov cuab yeej siv kho mob, European Commission tau tsim peb tsab cai lij choj EU los hloov qhov kev lees paub thawj zaug ntawm txhua lub xeev cov tswv cuab, kom cov kev cai hais txog kev lag luam ntawm cov khoom lag luam tuaj yeem sib haum xeeb.
EU MDR hais txog Txoj Cai Kho Mob Cov Khoom Siv Kho Mob (MDR) uas tau muab los ntawm EU (EU (EU) 2017/745), raws li cov cai ntawm Tshooj 123 ntawm MDR.MDR tau pib siv rau lub Tsib Hlis 26, 2017 thiab tau hloov pauv cov lus qhia yav dhau los Cov Khoom Siv Kho Mob (MDD 93/42/EEC) thiab Cov Lus Qhia Txog Cov Khoom Siv Khomob (AEDD) txij li lub Tsib Hlis 26, 2020, Daim Ntawv Qhia Txog Kev Kho Mob Implantable (AIMDD 90). /385/EEC).
Piv nrog rau Cov Lus Qhia Txog Kev Kho Mob (MDD), MDR yog qhov nruj dua ntawm kev tswj hwm kev pheej hmoo ntawm cov khoom lag luam, kev ua tau zoo ntawm cov khoom lag luam thiab cov qauv kev nyab xeeb, kev soj ntsuam kev soj ntsuam, nrog rau kev ceev faj tom qab kev lag luam thiab kev saib xyuas cov khoom.Nws tseem yog ib qho kev sib tw loj rau cov chaw tsim khoom kev tswj hwm kev ua haujlwm zoo thiab kev nyab xeeb ntawm cov khoom.
Qhov kev ua tiav ntawm MDR daim ntawv pov thawj pom tau tias yog tus qauv siab thiab zoo ntawm Joytech Medical cov khoom thiab kev lees paub ntawm EU kev ua lag luam.Joytech Medical yuav tau txais daim ntawv pov thawj MDR CE raws li txoj hauv kev tshiab txhim kho kom nkag siab ntxiv rau kev lag luam thoob ntiaj teb thiab pab txhawb rau kev lag luam kho mob thoob ntiaj teb.
