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ISO 13485 Daim Ntawv Pov Thawj thiab Kev Muaj Peev Xwm Tshaj Lij: FCE Kev Pabcuam rau Cov Khoom Siv Kho Mob Zoo Nkauj

 

FCEzoo siab tau txais ntawv pov thawj raws li ISO13485, thoob ntiaj teb lees paub tus qauv rau kev tswj xyuas zoo hauv kev tsim khoom siv kho mob. Daim ntawv pov thawj no qhia txog peb txoj kev cog lus kom ua tau raws li qhov yuav tsum tau ua kom nruj rau cov khoom siv kho mob, ua kom muaj kev ntseeg siab, traceability, thiab kev ua tau zoo hauv txhua qhov txheej txheem. Ua ke nrog peb lub xeev-ntawm-lub-kos duab chav 100,000 chav huv, peb muaj cov txheej txheem thiab kev txawj ntse los tsim cov khoom uas ua tau raws li cov qauv kev nyab xeeb thiab kev ua haujlwm siab tshaj plaws, suav nrog kev ua raws li FDA cov cai.

Koom tes nrog Zoo li Bio: Aesthetic Device Innovation


Zoo li Bio, ib lub tuam txhab tshwj xeeb hauv cov khoom siv kho mob zoo nkauj, nrhiav ib tus neeg muag khoom nrog kev tsim vaj tsev muaj zog thiab kev tsim kho muaj peev xwm nrog rau ISO13485-tsim chav huv huv. Thaum ntxov hauv lawv txoj kev tshawb nrhiav, lawv tau txheeb xyuas FCE ua tus khub zoo tshaj plaws. Zoo li Bio pib muab 3D qauv ntawm lawv cov cuab yeej, uas yuav tsum tau ua kom zoo dua qub thiab zoo nkauj.

FCE tau ua qhov kev tshuaj xyuas dav dav ntawm tus qauv tsim thiab npaj ntau qhov kev ua kom zoo raws li peb cov kev tsim khoom siv dav. Sib npaug kev ua haujlwm thiab kev ua kom zoo nkauj, peb tau koom tes nrog cov neeg siv khoom los ntawm ntau qhov kev rov ua dua tshiab, thaum kawg ua tiav cov kev daws teeb meem uas dhau qhov lawv xav tau.

Kev sib tw hauv Kev Cai Xim Sib Tw rauCov ntawv thov kho mob

Muab qhov zoo nkauj ntawm cov khoom, Zoo li Bio thov ntsuab ua cov xim thawj. Ua kom tiav qhov yuav tsum tau kov yeej cov teeb meem tseem ceeb, suav nrog kev xaiv cov khoom tsim nyog, ua kom cov xim sib xyaw ua ke, thiab tswj cov khoom lag luam siab.

FCE pom zoo rau kev kho mob-qib yas resins ua ke nrog cov khoom noj khoom haus-xim xim additives kom ua tiav qhov xav tau. Tom qab tsim cov qauv thawj zaug, cov xim tau zoo-tu los ntawm kev sib piv nrog cov neeg siv khoom nyiam thiab cov qauv xim swatches. Txoj kev nruj no ua rau muaj kev cai xim xim uas ua tau raws li tus neeg siv khoom xav tau.

Leveraging DHR rau Traceability thiab Quality Assurance

ISO 13485 Kev ua raws cai yuav tsum muaj cov ntaub ntawv ceev faj thiab kev taug qab thoob plaws hauv kev tsim khoom. Ntawm FCE, peb ua raws li Kev Tswj Xyuas Cov Ntaub Ntawv Keeb Kwm (DHR) muaj zog, sau tseg txhua yam ntawm kev tsim khoom, suav nrog cov lej batch, tsis muaj, thiab cov ntaub ntawv tswj xyuas zoo. Qhov no ua rau peb taug qab cov ntaub ntawv tsim tawm mus txog tsib xyoos, kom ntseeg tau tias tsis muaj kev lav phib xaub thiab kev txhawb nqa tom qab tsim khoom.

Lub Sijhawm Ua Tau Zoo Los Ntawm Kev Sib Koom Tes

FCE kev mob siab rau kev ua tau zoo, nruj me ntsis ua raws li ISO13485 cov qauv, thiab muaj peev xwm los daws cov teeb meem kev tsim khoom nyuaj tau ua rau peb muaj lub koob npe nrov. Peb kev koom tes nrog Zoo li Bio tau hloov mus rau hauv kev sib koom tes ntev, nrog rau ob lub tuam txhab tau txais txiaj ntsig los ntawm kev sib koom kev loj hlob thiab kev tsim kho tshiab.

Los ntawm kev sib txuas cov thev naus laus zis siab, cov txheej txheem ua tau zoo, thiab cov kev daws teeb meem, FCE txuas ntxiv teeb tsa cov qauv ntsuas rau qhov tseeb thiab kev ntseeg siab hauv kev tsim khoom siv kho mob.

kev cai-xim-muab

ISO 13485-Cov ntawv pov thawj

kho mob-device-manufacturing

precision-medical-device-solutions.


Post lub sij hawm: Nov-28-2024