Raws li Chav Kawm III cov cuab yeej siv kho mob siv nyob rau hauv siab - cov txheej txheem kev pheej hmoo ntawm kev mob plawv, cov koob tshuaj radiofrequency transseptal puncture yuav tsum ua raws li cov txheej txheem kev tswj hwm kev kho mob thoob ntiaj teb nruj heev thoob plaws tag nrho cov txheej txheem ntawm kev tshawb fawb thiab kev tsim kho, tsim khoom, thiab kev faib tawm. Dual ntawv pov thawj ntawmISO 9001: 2015thiabISO 13485 Kev Tswj Xyuas Kev Lag Luamua tus tseem ceeb tsim nyog rau manufacturers ntawm radiofrequency transseptal puncture koob kom nkag mus rau hauv lub thoob ntiaj teb kev ua lag luam, raws li zoo raws li ib tug tseem ceeb benchmark rau ntsuam xyuas standardized ntau lawm thiab cov khoom muaj kev ruaj ntseg. Kev tswj hwm kev ua raws cai tau dhau los ua ib qho ntawm cov kev sib tw tseem ceeb ntawm cov tuam txhab ua lag luam.

ISO 13485 Kev Tswj Xyuas Kev Lag LuamCov cuab yeej kho mob kev tswj hwm kev tswj xyuas cov ntawv pov thawj zoo yog qhov tseem ceeb uas yuav tsum muaj rau cov tuam txhab tsim cov khoom siv siab - kawg kev cuam tshuam. Tsim kom muaj kev tswj hwm lub neej tag nrho ntawm cov cuab yeej kho mob, tus qauv no tau teeb tsa cov kev cai nruj dua li cov khoom lag luam dav dav thoob plaws txhua qhov kev sib txuas ntawm cov xov tooj cua zaus transseptal puncture koob, suav nrog kev tswj cov khoom siv raw, cov txheej txheem tsim khoom, kev soj ntsuam zoo, kev ua kom tsis muaj menyuam thiab ntim khoom, thiab tom qab- muag traceability.

Hauv kev muab cov khoom siv raw, cov tuam txhab tsim khoom yuav tsum tsim kom muaj kev yuav khoom raws li kev tshawb fawb kom ntseeg tau tias kev kho mob -qib cov ntaub ntawv hlau ua tau raws li biocompatibility thiab mechanical kev ua tau zoo. Kev tsim khoom yuav tsum tau ua nyob rau hauv Chav Kawm 10,000 kev cob qhia huv, nrog rau kev tswj xyuas nruj ntawm kev ua haujlwm siab, kev kho saum npoo, sib dhos thiab txhua yam txheej txheem los tshem tawm cov kev pheej hmoo ntawm kev sib kis. Cov txheej txheem kev ntsuas cov khoom tiav tiav yuav tsum nyob rau hauv qhov chaw kom paub tseeb cov ntsiab lus tseem ceeb xws li kev ua haujlwm ntawm lub xov tooj cua, koob lub zog, thiab tsis muaj menyuam. Tau txais ISO 13485 daim ntawv pov thawj qhia tau hais tias lub chaw tsim khoom tsim cov txheej txheem ua tiav raws li kev tswj hwm kev kho mob thoob ntiaj teb thiab nws cov khoom muaj kev nyab xeeb siab rau kev siv tshuaj kho mob.

ISO 9001: 2015Kev tswj hwm kev tswj hwm kev ua haujlwm tau ntawv pov thawj nteg lub hauv paus rau cov qauv tsim thiab loj - teev ntau lawm. Kev tsom mus rau kev lag luam- kev tswj hwm kev ua haujlwm zoo thoob plaws, nws pab cov tuam txhab tsim kom muaj kev tswj hwm kev tsim khoom ruaj khov thiab ua haujlwm zoo, ua kom cov khoom zoo sib xws thiab txhim khu kev qha, thiab txo qis batch - mus rau -batch variation. Rau siab -cov cuab yeej kho mob muaj tseeb xws li xov tooj cua zaus transseptal puncture koob, kev ruaj ntseg zoo yog txuas ncaj qha rau cov txheej txheem kev nyab xeeb. Kev ua raws li ISO 9001 tau ua kom zoo tshaj qhov kev ua haujlwm ntau lawm, txo cov nqi tsis raug, thiab muab kev txhawb nqa rau kev tsim khoom loj thiab khoom siv thoob ntiaj teb.

Kev txhawb nqa los ntawm ob daim ntawv pov thawj, cov tuam txhab lag luam tuaj yeem ua tiav dhau los ntawm kev lag luam khoom siv kho mob thoob ntiaj teb thiab nkag mus rau cov lag luam tseem ceeb thoob plaws Europe, America, thiab Asia - thaj av Pacific. Hauv kev sib tw ua lag luam thoob ntiaj teb, cov tuam txhab tuav cov ntawv pov thawj dual tau txais kev lees paub yooj yim dua los ntawm cov tsev kho mob, cov chaw muag tshuaj kho mob, thiab cov tuam txhab tshuaj thoob ntiaj teb, ua rau lawv dhau los ua cov koom tes tseem ceeb hauv siab -kawg kev cuam tshuam cov khoom siv hluav taws xob. Tsis tas li ntawd, ntau lub tuam txhab ua lag luam tseem tau txais cov ntawv pov thawj tshwj xeeb hauv cheeb tsam xws li EU CE thiab US FDA txhawm rau nthuav dav kev lag luam thiab ntxiv dag zog rau kev sib tw thoob ntiaj teb.

Rau cov tuam txhab tsim hluav taws xob hauv tsev ntawm cov koob tshuaj radiofrequency transseptal puncture koob, hauv - kev sib sib zog nqus nrog cov ntawv pov thawj thoob ntiaj teb tsis yog tsuas yog kev xav tau ntawm kev ua lag luam xwb, tab sis kuj yog ib txoj hauv kev tseem ceeb rau kev tsav cov txheej txheem kev lag luam thiab txhim kho cov khoom zoo. Nrog kev nthuav dav sai ntawm lub ntiaj teb kev cuam tshuam cov khoom siv hluav taws xob ua lag luam thiab txuas ntxiv txhim kho cov qauv kev tswj hwm, tsuas yog ua raws li cov hauv paus ntsiab lus thiab txuas ntxiv txhim kho cov kev tswj xyuas kom zoo tuaj yeem ua lag luam tau txais kev ruaj ntseg hauv kev sib tw thoob ntiaj teb thiab ua kom lub ntiaj teb nthuav dav ntawm cov khoom siv hauv tsev siab - xaus kev cuam tshuam.