Kev tswj hwm thoob ntiaj teb tseem yog qhov mob tseem ceeb rau cov kws tsim khoom siv tshuaj tua kab mob OEMs. Cov cheeb tsam sib txawv tau tsim cov kev cai sib txawv rau cov khoom siv traceability, txheej txheem validation thiab cov ntaub ntawv technical. Ntau cov khoom lag luam feem ntau cuam tshuam cov ntaub ntawv pov thawj nrog cov khoom siv kho mob tiav. ISO13485 kev soj ntsuam kev tshawb pom ntawm rab koob cannula feem ntau yog los ntawm cov ntaub ntawv raw khoom tsis tiav, cov ntaub ntawv pov thawj cov txheej txheem uas ploj lawm lossis tsis muaj pov thawj biocompatibility tsis txaus. Thaum rab koob cannula tau koom ua ke nrog laser txiav hypo raj, tag nrho cov ntaub ntawv sib dhos yuav tsum tau npog ob qho tib si. EU MDR txoj cai yuav tsum muaj cov ntaub ntawv ntxaws ntxaws suav nrog kev soj ntsuam kev pheej hmoo, tom qab- cov ntaub ntawv soj ntsuam kev lag luam. US FDA cia siab tias cov khoom ua cim thiab cov lus ceeb toom qaug zog rau cov khoom siv hauv cov hlab ntsha cannula. Ntau lub tuam txhab me me tsuas yog tsom rau cov khoom lag luam machining thiab tsis muaj kev tswj hwm cov ntaub ntawv npaj muaj peev xwm. Tsis yog -kev ua raws cai yuav ua rau OEM cov neeg siv npe ncua sijhawm thiab kev nkag mus rau kev lag luam thaiv.

Lub hauv paus ntsiab lus ua haujlwm ntawm kev ua raws cai rau rab koob cannula yog tsim kom muaj kev pheej hmoo -raws li qhov system zoo uas npog tag nrho cov khoom lag luam lifecycle. ISO 13485 txhais cov kev tswj xyuas zoo rau cov khoom siv kho mob, tswj kev tsim, kev yuav khoom, machining, kho nto, ntim thiab traceability. Kev soj ntsuam kev pheej hmoo txheeb xyuas cov teeb meem cuam tshuam nrog rab koob cannula: hlab ntsha perforation, thrombus, cov khoom tawg thiab kev sib kis. Kev tswj hwm kev pheej hmoo suav nrog kev xaiv cov khoom siv, kev sib tsoo zoo tswj, kev sim qaug zog thiab kev tsim khoom huv. Tag nrho cov txheej txheem tsim khoom suav nrog laser txiav ntawm qhov sib tw hypo tube yuav tsum tau lees paub. Cov ntaub ntawv tswj kev tsim cov ntaub ntawv khaws cov ntaub ntawv tsim tawm, tso tawm, pov thawj thiab siv tau cov ntaub ntawv. Batch traceability system txuas tiav koob cannula sib dhos rov qab mus rau raw tubing coil, tshav kub ntau, ua cov ntaub ntawv thiab cov ntawv xeem. Cov koom haum tswj xyuas seb cov chaw tsim khoom lag luam puas tuaj yeem tsim cov khoom lag luam raws li cov kev cai ua ntej thiab kev nyab xeeb kev ua haujlwm.

Koob cannula txoj cai tswj kev ua raws cai yog cais los ntawm lub hom phiaj kev lag luam. ISO13485: 2015 yog lub hauv paus thoob ntiaj teb daim ntawv pov thawj zoo, yuav tsum tau muab cov koob cannula thiab hypo raj sib dhos rau feem ntau cov kev kho mob OEMs. EU MDR kev ua raws cai xav tau cov ntaub ntawv thev naus laus zis, cov ntaub ntawv tswj hwm kev pheej hmoo thiab ceeb toom lub cev tshawb xyuas rau cov khoom siv hauv chav kawm III kev cuam tshuam. US FDA QSR txoj cai siv rau cov khoom muag hauv Tebchaws Meskas, xav tau cov ntaub ntawv keeb kwm tsim thiab cov ntaub ntawv tus tswv. Rau kev ua lag luam Nyij Pooj, PMDA kev xa khoom xav tau cov ntaub ntawv kuaj cov khoom siv roj ntsha thiab cov txheej txheem tsim khoom siv daim ntawv tshaj tawm. Daim ntawv thov cannula sib txawv coj cov kev pheej hmoo sib txawv: coronary thiab neurological intravascular koob cannula belongs rau qib siab - kev pheej hmoo, thaum kuaj zis cannula muaj kev pheej hmoo tsawg dua. Siab-kev pheej hmoo cannula ua ke nrog muab kauv txiav hypo raj xav tau ntau dua cov khoom siv kho tshuab thiab cov khoom siv roj ntsha piv nrog tsawg- daim ntawv thov kev pheej hmoo.

Cov txheej txheem kev ua haujlwm zoo suav nrog kev teeb tsa kev ua haujlwm zoo, kev tsim qauv, kev siv tau zoo, cov ntaub ntawv thiab kev tshuaj xyuas kev npaj. Ua ntej siv ISO13485 qhov system zoo, tsim cov ntaub ntawv tswj, tswj cov ntaub ntawv thiab cov txheej txheem kho kom raug. Rau txhua lub koob cannula kev cai project, ua tiav kev tswj hwm: txhais cov tswv yim tsim los ntawm cov neeg siv khoom xav tau, tsim cov khoom tsim tawm nrog rau cannula kos duab thiab hypo raj txiav cov ntaub ntawv, ua tiav cov ntaub ntawv pov thawj tsim thiab validation xeem. Ua qhov kev soj ntsuam kev pheej hmoo thiab kev ntsuas kev pheej hmoo. Siv tau tag nrho cov txheej txheem tseem ceeb: laser txiav, cannula tip sib tsoo, vuam, electropolishing, ntim huv. Khaws tag nrho cov ntaub ntawv traceability los ntawm raw cov ntaub ntawv pov thawj mus rau tiav batch xeem daim ntawv qhia. Npaj cov ntaub ntawv xws li cov ntaub ntawv cov ntaub ntawv, cov ntaub ntawv ntsuam xyuas txhua yam, daim ntawv qhia biocompatibility, cov ntaub ntawv txheej txheem tsim khoom. Khaws cov ntaub ntawv tus tswv thiab tsim cov ntaub ntawv keeb kwm. Ua ntej thib peb- tog neeg soj ntsuam lossis ceeb toom rau kev tshuaj xyuas lub cev, ua qhov kev tshuaj xyuas sab hauv. Tag nrho cov khoom uas tsis yog{11}}kev sib raug zoo yuav tsum raug kaw nrog kev kho thiab tiv thaiv. Ua raws li daim ntawv pov thawj rov ua dua tshiab rau ISO9001: 2015 thiab ISO13485.

Los ntawm kev paub txog kev tswj hwm txoj haujlwm tiag tiag, cov ntaub ntawv tsis tiav traceability yog qhov tsis zoo tshaj plaws -kev ua raws li ISO13485 kev tshuaj xyuas. Hauv ib qho kev soj ntsuam ntawm tus neeg muag khoom cannula, tus kws tshuaj ntsuam xyuas tsis tuaj yeem taug qab cov koob tiav cannula batch rov qab rau Nitinol coil cua sov tooj, uas ua rau qhov tsis zoo ntawm -. Txhim kho batch tswj system los txuas txhua kauj ruam ua daws qhov sib txawv no. Lwm qhov OEM MDR qhov project tsis muaj kev pheej hmoo tsom xam npog cannula-hypotube sib koom ua ke puas tsuaj, yog li cov ntaub ntawv thev naus laus zis tau rov qab los ntxiv. Ntau tus neeg muag khoom yuam kev xav tias ISO13485 daim ntawv pov thawj rau cov khoom hloov pauv cov ntawv sau npe tiav; Qhov tseeb, daim ntawv pov thawj tivthaiv tsuas yog ua pov thawj tus neeg muag khoom zoo, OEM tseem yuav tsum tau sau npe rau kev cuam tshuam zaum kawg. Tag nrho cov txheej txheem validation cov ntaub ntawv yuav tsum muaj lub hom phiaj pov thawj, tsis tsuas yog cov ntaub ntawv txheej txheem. Internal audit yuav tsum simulate ceeb toom lub cev soj ntsuam thiab nrhiav kom tau raws li qhov sib txawv ua ntej. Thaum cov neeg siv khoom hloov kho cannula tsim lossis hypo tube txiav qauv, tsim kev hloov pauv yuav tsum tau ua thiab hloov kho cov ntaub ntawv txaus ntshai raws li.

Raws li cov ntsiab lus, kev ua raws cai thoob ntiaj teb yog qhov yuav tsum tau ua kom zoo dua li cov ntaub ntawv rau cov kws tsim khoom siv rab koob cannula. Kev ua raws cai yuav tsum tau muab tso rau hauv txhua theem ntawm kev tsim, kev yuav khoom, kev tsim khoom mus rau kev xa khoom. Risk-raws li kev xav yog lub hauv paus ntawm ISO13485, MDR thiab FDA QSR. Koob cannula thiab nws qhov sib txuam hypo tube sib dhos tsis tuaj yeem raug soj ntsuam sib cais hauv cov ntaub ntawv tswj hwm. Raws li kev tswj hwm kev noj qab haus huv thoob ntiaj teb dhau los ua nruj zuj zus, cov tuam txhab tsim khoom yuav tsum nqis peev hauv kev tswj hwm thiab pab pawg muaj peev xwm. Kev ua raws cai yav tom ntej yuav tsom mus rau tom qab- kev soj ntsuam kev lag luam thiab cov ntaub ntawv pov thawj kho mob rau lub sijhawm ntev - cov khoom siv cog qoob loo. Koob cannula cov neeg muag khoom yuav tsum tswj hwm cov txheej txheem zoo ISO13485, tsim kom tiav kev tswj hwm thiab kev tswj hwm kev pheej hmoo ua haujlwm, thiab koom tes nrog OEM cov neeg siv khoom los npaj cov ntaub ntawv kev txawj ntse, txhawb kev lag luam thoob ntiaj teb kom nkag mus rau cov khoom siv kho mob tsawg kawg nkaus.