Quwin tau txais txiaj ntsig 240 lub thawv ntawm kub-nias Holder xaj rau North American kev kho mob loj, ua tiav qhov kev ua lag luam loj hauv kev ua lag luam siab kawg

Apr 01, 2025

Tso lus

Lub Plaub Hlis 1, 2025, Quwin tshaj tawm cov kev ua tiav ntawm 240 lub thawv ntawm cov neeg kho mob qib siab uas txhawb nqa cov teb .

181
182

{{01.-qib-qib zoo yeej kev lees paub los ntawm cov neeg muas zaub tom qab

Cov Hooks kub nias tau xa lub sijhawm no muaj cov qauv kev lag luam:

- Hla ISO 13485 Kev Kho Mob Ntaus Ntawv Txheej Txheem

- Ua tau raws li FDA 21 CFR 177.2600 tus qauv khomob

- siv biocomple puab kub yaj adhesive mis

- Kev tsis muaj menyuam ua kom tsis pub muaj Eo / Gamma Ray Dual tus qauv

Kev Ntsuas Cov Neeg Siv: "Cov khoom ua haujlwm tau ua tiav ntawm cov hlua khi ntawm peb cov khoom saib xyuas cov mob plawv {}}"

 

2.} Cov txheej txheem tswj tau zoo

Txhawm rau kom muaj kev ntseeg tau ntawm cov khoom siv kho mob:

- Cov ntaub ntawv raw: siv US FDA-ntawv pov thawj substrates

- Ntau Lawm: Tshwj xeeb ntau lawm hauv chav kawm 1,000 plua plav ua haujlwm pub dawb

- Kev Kuaj: Kev siv 100% Puv tshuaj xyuas tag nrho

- ntim khoom: Kho mob-kom huv ib puag ncig

 

3. thev naus laus zis thev naus laus zis kev lag luam mob ntsiab lus

Cov khoom lag luam tawg ua kom zoo:

- Ua tiav 72 teev ntawm kev sib txuas lus txuas ntxiv yam tsis tau txais kev

- tsis muaj qhov chaw nyob lossis tawv nqaij khaus thaum muab tshem tawm

- tswj cov viscosity ruaj khov ntawm lub cev kub

- Txhawb kev nkag mus rau cov duab kho mob xws li x-rays / ct

 

4. Cov tswv yim npaj tau ua tiav cov txiaj ntsig thawj zaug

Qhov tseem ceeb deb ntawm qhov kev txiav txim no:

- thawj qhov kev txiav txim kom nkag mus rau North American Medical Raw saw hlau

- Nws cia siab tias yuav tsav txhua qhov kev muag khoom txhua xyoo nce ntawm 30 lab Yuan

- Ua kom nrawm dua cov kev txhim kho ntawm lub tuam txhab kev tsim kho kho mob

 

5.} tsim tsa txoj kev sib koom tes ntev

Ob tog tau kos npe:

- Peb-xyoo Daim Ntawv Cog Lus Hloov Kho

- Ib qho kev tshawb fawb thiab kev txhim kho mem remorandum

- txoj kev npaj sib txuas zoo ua kom zoo

Cov qhua tuaj noj mov tau cog lus tias yuav suav nrog Quwin hauv cov khoom xa khoom tseem ceeb .

 

QWIN General Managen Wei Wenbin tau hais tias: "Cov kev qhia kho mob yog qhov ua tau zoo rau kev ua haujlwm GMP teb .

Xa kev nug