Quality Management System
 

Ntawm Roosin Medical, qhov zoo yog lub hauv paus ntawm peb txoj kev cog lus rau kev kho mob thoob ntiaj teb. Txij li thaum peb nrhiav tau nyob rau hauv1996, peb tau tsim kom muaj Kev Tswj Xyuas Kev Tswj Xyuas Zoo (QMS) uas koom ua ke nrog kev tshawb fawb txog kev tsim kho tshiab nrog kev ua raws cai nruj.

Manufacturing Excellence

Peb ntau lawm yog ua nyob rau hauv a30,000 SQM chaw,featuring ibChav Kawm 100,000 (ISO Chav Kawm 8) kev cob qhia huvlos xyuas kom meej cov qauv siab tshaj plaws ntawm kev nyiam huv thiab kev nyab xeeb rau kev tsim khoom siv kho mob.

Traceability

Peb siv cov txheej txheem traceability tag nrho uas saib xyuas tag nrho cov khoom lag luam lub neej voj voog -los ntawm kev yuav khoom raw mus rau qhov kawg xa khoom - xyuas kom txhua batch ua tau raws li cov ntaub ntawv teev tseg.

Sterile Production Control

Siv thev naus laus zis ua kom tsis muaj menyuam thiab kev saib xyuas ib puag ncig, peb lav qhov tsis muaj menyuam thiab kev ncaj ncees ntawm peb cov kev kho mob, tiv thaiv cov neeg mob thoob plaws 87 lub tebchaws.

 
International Certifications
 

Roosin Medical ua raws li cov kev cai nruj tshaj plaws thoob ntiaj teb kev cai. Peb cov khoom muaj ntawv pov thawj rau kev nyab xeeb thiab kev ua tau zoo los ntawm cov thawj coj saib xyuas kev noj qab haus huv thoob ntiaj teb.

 Peb Cov Kev Cai Tswj Xyuas Cov Ntaub Ntawv suav nrog:

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CE IIb
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FDA
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ISO 13485 Kev Tswj Xyuas Kev Lag Luam
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MDSAP
Cov txheej txheem tswj xyuas nruj nruj

Peb siv ntau-theem Kev Tswj Xyuas Zoo (QC) raws tu qauv los xyuas kom meej xoom-kev tsim khoom tsis raug thiab kev ntseeg tau ntawm kev kho mob.

 

Incoming Inspection (IQC):Kev soj ntsuam nruj ntawm tag nrho cov khoom siv raw thiab cov khoom tiv thaiv kev ua haujlwm ua ntej lawv nkag mus rau cov kab ntau lawm.

 

Hauv -Kev Tshawb Xyuas Txheej Txheem (IPQC):Kev soj ntsuam tas mus li thiab tiag tiag- lub sijhawm sim thaum lub sijhawm tsim khoom los tswj cov txheej txheem kev ruaj ntseg thiab cov khoom sib xws.

 

Kev soj ntsuam zaum kawg (FQC/OQC):Kev soj ntsuam kev ua tau zoo thiab ntim cov kev ntseeg siab ntawm cov khoom tiav kom ntseeg tau tias txhua yam khoom tuaj txog ntawm lub chaw kho mob tau npaj rau kev siv tshuaj kho mob.

 

Tiv Tauj PebYog muaj lus nug

Koj tuaj yeem tiv tauj peb hauv xov tooj, email lossis online daim ntawv hauv qab no. Peb tus kws tshaj lij yuav hu koj rov qab sai.

Hu rau tam sim no!