Xov xwm

Peb cov lus qhia ntawm cov cuab yeej kho mob tsis zoo tshwm sim rov qab

Database, cov khoom npe thiab cov chaw tsim khoom npe yog peb cov lus qhia tseem ceeb ntawm kev saib xyuas qhov xwm txheej tsis zoo.

Kev xa rov qab ntawm cov cuab yeej siv kho mob tsis zoo tuaj yeem ua tiav hauv cov kev taw qhia ntawm cov ntaub ntawv, thiab cov ntaub ntawv sib txawv muaj lawv tus yam ntxwv. Piv txwv li, Tuam Tshoj cov khoom siv kho mob tsis zoo cov ntaub ntawv xov xwm tsis tu ncua qhia txog cov xwm txheej tsis zoo ntawm qee yam khoom, thaum cov khoom siv kho mob tsis zoo uas tau teev tseg hauv cov ntawv ceeb toom kev kho mob feem ntau yog los ntawm Tebchaws Meskas, United Kingdom, Australia thiab Canada Medical device. ceeb toom lossis rov qab cov ntaub ntawv hauv tsev thiab cheeb tsam tsis yog cov ntaub ntawv qhia hauv tsev; MAUDE cov ntaub ntawv hauv Tebchaws Meskas yog cov ntaub ntawv tag nrho, tsuav yog cov khoom siv khomob tsis zoo tau tshaj tawm raws li FDA cov cai ntawm Tebchaws Meskas yuav nkag mus rau hauv cov ntaub ntawv; Cov cuab yeej siv kho mob tsis zoo / rov qab / ceeb toom cov ntaub ntawv ntsig txog cov ntaub ntawv ntawm lub tebchaws thiab cheeb tsam xws li United Kingdom, Canada, Australia thiab Lub teb chaws Yelemees yuav hloov kho tsis tu ncua. Txhawm rau khaws cov cuab yeej kho mob tsis zoo nyob rau hauv cov kev taw qhia ntawm cov ntaub ntawv, nws tuaj yeem raug tshuaj xyuas raws li cov lus tseem ceeb, thiab nws tseem tuaj yeem raug muab rov qab kom raug los ntawm kev txwv lub sijhawm lossis lo lus tseem ceeb.

Txhawm rau nqa tawm cov khoom siv kho mob tsis zoo rau kev rov qab los ntawm cov khoom lag luam npe, koj tuaj yeem nkag mus rau cov khoom siv kho mob uas xav tau lub npe khoom ntawm nplooj ntawv khaws cov ntaub ntawv rov qab los, thiab feem ntau tsis tas yuav nkag mus rau cov npe khoom tshwj xeeb.

Thaum tshawb nrhiav raws li lub npe ntawm cov cuab yeej siv kho mob, yog tias lub tuam txhab yog lub tuam txhab nyiaj txiag txawv teb chaws, nws yuav tsum tau them sai sai rau qhov sib txawv ntawm cov npe ntawm lub tuam txhab, xws li cov ntaub ntawv, cov ntawv luv, thiab lwm yam.

Kev tshuaj xyuas cov xwm txheej tsis zoo los ntawm cov xwm txheej tshwj xeeb

Cov ntsiab lus ntawm cov cuab yeej kho mob tsis zoo rau kev soj ntsuam kev tshawb fawb tsab ntawv ceeb toom yuav suav nrog tab sis tsis txwv rau cov ntsiab lus luv luv ntawm lub hom phiaj kev saib xyuas thiab kev saib xyuas cov phiaj xwm kev kho mob tsis zoo; saib xyuas cov ntaub ntawv; lub sij hawm ntau ntawm qhov kev tshwm sim tsis zoo retrieval; tus naj npawb ntawm cov xwm txheej tsis zoo; qhov chaw qhia; ua rau muaj xwm txheej phem; qhov tshwm sim ntawm cov xwm txheej tsis zoo; feem ntau ntawm cov xwm txheej tsis zoo; kev ntsuas coj los rau cov xwm txheej tsis zoo; thiab; Kev soj ntsuam cov ntaub ntawv thiab kev soj ntsuam cov txheej txheem tuaj yeem muab kev tshoov siab rau kev tshuaj xyuas, kev saib xyuas tom qab kev lag luam ntawm cov khoom, lossis kev tswj hwm kev pheej hmoo ntawm kev tsim khoom lag luam.

Raws li cov ntaub ntawv loj, 219 daim ntaub ntawv tau muab los ntawm kev txwv "productcode" rau lub Rau Hli 2019. Tom qab tshem tawm 19 daim ntawm cov ntaub ntawv tsis zoo tshwm sim, qhov seem 200 tau suav nrog hauv kev tshuaj xyuas. Cov ntaub ntawv hauv cov ntaub ntawv tau muab rho tawm ib los ntawm ib qho, siv Microsoft Excel software sau cov ntaub ntawv los ntawm lub hauv paus ntawm daim ntawv tshaj tawm, cov ntaub ntawv kho mob ntsig txog (nrog rau lub npe ntawm cov chaw tsim khoom, lub npe khoom, hom khoom siv kho mob, teeb meem ntawm cov cuab yeej kho mob) , lub sijhawm tshwm sim ntawm cov xwm txheej tsis zoo, lub sijhawm FDA tau txais cov xwm txheej tsis zoo, hom kev tshwm sim tsis zoo, qhov ua rau muaj qhov tshwm sim tsis zoo, thiab tom qab ntawd txheeb xyuas qhov chaw ntawm cov xwm txheej tsis zoo Cov ntsiab lus tseem ceeb ntawm cov xwm txheej tsis zoo tau sau tseg, thiab kev txhim kho kev ntsuas yog muab tso rau pem hauv ntej ntawm kev ua haujlwm, tsim prosthesis thiab postoperative laus. Cov txheej txheem soj ntsuam saum toj no thiab cov ntsiab lus tuaj yeem siv los ua kev siv rau kev soj ntsuam ntawm cov khoom siv kho mob zoo sib xws.

Kev tshuaj xyuas cov xwm txheej tsis zoo los txhim kho qib kev tswj hwm kev pheej hmoo

Cov ntsiab lus thiab kev tsom xam ntawm cov khoom siv kho mob tsis zoo muaj qee yam kev siv tseem ceeb rau cov chaw kho mob tswj hwm cov tuam tsev, cov tuam txhab tsim khoom thiab kev ua haujlwm thiab cov neeg siv los tswj kev pheej hmoo. Rau lub tuam tsev tswj hwm, kev tsim thiab kev kho dua tshiab ntawm cov cuab yeej siv kho mob cov cai, cov cai thiab cov ntaub ntawv pov thawj tuaj yeem ua tiav nrog rau kev soj ntsuam cov txiaj ntsig ntawm cov xwm txheej tsis zoo, txhawm rau ua kom muaj kev pheej hmoo thiab kev tswj xyuas cov cuab yeej siv kho mob muaj cov cai thiab cov cai ua raws. . Txhim khu kev saib xyuas tom qab kev lag luam ntawm cov cuab yeej kho mob, sau thiab sau cov ntsiab lus tsis zoo, ceeb toom thiab rov qab cov ntaub ntawv ntawm cov cuab yeej kho mob tsis tu ncua, thiab tshaj tawm cov lus tshaj tawm raws sijhawm. Nyob rau tib lub sijhawm, ntxiv dag zog rau kev saib xyuas ntawm cov chaw tsim khoom siv kho mob, ua qauv rau lawv cov txheej txheem tsim khoom, thiab txo qis qhov tshwm sim tsis zoo los ntawm qhov chaw. Tsis tas li ntawd, peb yuav tsum txuas ntxiv txhawb kev tshawb fawb txog kev saib xyuas cov cuab yeej kho mob thiab tsim kom muaj kev ntsuam xyuas raws li kev tswj hwm kev pheej hmoo.

Cov tsev kho mob yuav tsum ntxiv dag zog rau kev cob qhia thiab kev tswj hwm, kom cov kws kho mob tuaj yeem paub cov txheej txheem kev ua haujlwm thiab cov cuab yeej ua haujlwm, thiab txo qhov tshwm sim ntawm qhov tshwm sim tsis zoo. Txhawm rau ntxiv dag zog rau kev sib xyaw ua ke ntawm kev kho mob thiab kev tsim vaj tsev, thiab hais kom cov kws kho mob sib txuas lus nrog cov kws kho mob tsim cov kws kho mob txog cov teeb meem pom hauv kev siv cov cuab yeej kho mob, kom cov kws kho mob tuaj yeem nkag siab ntau dua ntawm cov cuab yeej siv kho mob siv, thiab tseem pab tau. cov cuab yeej kho mob tsim engineers kom tsim tau zoo dua lossis txhim kho cov cuab yeej kho mob. Tsis tas li ntawd, cov kev taw qhia txog kev kho mob kho mob yuav tsum tau ntxiv dag zog rau cov neeg mob nco txog cov ntsiab lus tseem ceeb los tiv thaiv kev ua tsis tiav ntxov ntawm kev cog qoob loo vim kev ua haujlwm ntxov ntxov lossis kev ua haujlwm tsis raug. Nyob rau tib lub sijhawm, cov kws kho mob yuav tsum txhim kho lawv txoj kev paub txog cov khoom siv kho mob tsis zoo, zam kev pheej hmoo ntawm kev siv cov cuab yeej kho mob, thiab sau sijhawm thiab qhia txog cov xwm txheej tsis zoo ntawm cov cuab yeej kho mob.