Cov cuab yeej kho mob nrhiav tau · Cov neeg yuav khoom siv phau ntawv qhia
Kev ntsuam xyuas cov cuab yeej phais cov tuam txhab lag luam xav tau ntau tshaj qhov sib piv cov catalog loj thiab nqi tsev. Kev tshuaj xyuas txhim khu kev qha tshuaj xyuas cov chaw tsim khoom raws li kev cai lij choj, kev ua haujlwm zoo, cov khoom lag luam tshwj xeeb raws li kev tswj hwm, cov ntaub ntawv, kev tswj cov txheej txheem, traceability, cov qauv, kev xa khoom, thiab kev txhawb nqa tom qab muag. Daim ntawv teev npe 12-taw qhia no hloov cov kev xav tau mus rau hauv cov txheej txheem kev xaiv tus neeg xa khoom rov qab.
Koj ntsuas tus kws tsim khoom siv phais mob li cas?
Pib nrog tus neeg siv cov lus qhia tshwj xeeb, tom qab ntawd ntsuas txhua tus neeg sib tw hauv plaub theem: kev tshuaj xyuas cov ntaub ntawv, kev sib tham txog kev ua haujlwm, kev sim ua qauv, thiab - qhov twg muaj kev pheej hmoo ua rau nws - kev soj ntsuam tej thaj chaw deb lossis ntawm qhov chaw. Tsis txhob tso cai rau tus neeg muag khoom raws li daim ntawv pov thawj PDF, lub vev xaib thov, lossis cov qauv pom tau zoo.
Cov lus teb luv luv zoo tshaj plaws: xaiv cov chaw tsim khoom uas muab cov ntaub ntawv pov thawj muaj zog tshaj plaws rau koj cov cuab yeej tshwj xeeb thiab kev ua lag luam - tsis tas yuav yog lub tuam txhab nrog cov npe khoom ntev tshaj plaws lossis cov nqe lus qis tshaj.
Txhais koj cov kev xav tau ua ntej hu rau cov neeg muab khoom
Ib tus neeg muag khoom tsis tuaj yeem muab cov lus muaj txiaj ntsig lossis kev ua raws li pob khoom kom txog thaum cov khoom npaj tau raug txhais kom meej. Npaj ib daim ntawv qhia luv luv ua ntej tsim cov npe luv.
- Cov cuab yeej siv thiab npaj siv: ntsuas lub npe, txheej txheem, rov siv tau lossis siv ib zaug, thiab seb nws yog muab los ntawm ib leeg lossis ua ib feem ntawm kev cog ntoo.
- Lub hom phiaj kev lag luam: lub teb chaws ntawm kev muag khoom, kev faib cov cuab yeej siv, kev tso npe siv tau, hom lus, daim ntawv lo, thiab cov neeg xa khoom lossis cov neeg sawv cev muaj cai.
- Technical specification: qhov ntev, kam rau ua, qib khoom, hardness, nto tiav, interface geometry, drawings, thiab xeem txoj kev.
- Kev Ua Haujlwm: ntxuav lub xeev, passivation, ntim, kom tsis muaj menyuam raws li txoj cai, kom tsis muaj menyuam sib raug zoo, thiab siv tau cov lus qhia rov ua dua yog siv tau.
- Kev lag luam Scope: kwv yees ntim, thawj qhov kev txiav txim, lub hom phiaj ua lub sij hawm, ntim kev teeb tsa, daim ntawv ntiag tug, thiab cov ntaub ntawv xav tau.
Tshawb xyuas cov chaw tsim khoom Cov khoom lag luam orthopedic tuaj yeem pab txhim kho seb nws qhov kev tsim khoom ib txwm zoo li cas rau kev yuav khoom. Catalog dav ib leeg, txawm li cas los xij, tsis ua kom muaj peev xwm rau txhua yam khoom siv.
12-Point Checklist rau Surgical Instrument Manufacturers
- Paub meej tias cov chaw tsim khoom raug cai thiab lub luag haujlwm ntawm qhov chaw Qhia seb leej twg yog tus tswv ntawm lub cuab yeej tsim, leej twg tsim txhua yam khoom, leej twg ua tiav thiab ntim khoom, thiab leej twg tso cov khoom tiav. Sau chaw nyob thiab outsourced txheej txheem tseem ceeb.
- Txheeb xyuas qhov kev tswj xyuas zoo Thov daim ntawv pov thawj ISO 13485 tam sim no thiab txheeb xyuas lub koom haum lub npe, chaw tsim khoom, chaw tsim khoom, daim ntawv pov thawj, daim ntawv pov thawj lub cev, kev lees paub, daim ntawv pov thawj raws li txoj cai, thiab hnub tas sij hawm.
- Txheeb xyuas cov khoom lag luam tshwj xeeb kev tso cai ua lag luam Sib tw cov khoom lag luam, qauv, npaj siv, kev faib tawm, thiab cov chaw tsim khoom raug cai rau cov ntaub ntawv xav tau hauv txhua lub khw muag khoom. Kev sau npe ntawm tuam txhab tsis zoo ib yam li cov khoom tshem tawm lossis kev pom zoo.
- Kev tshuaj xyuas cov ntaub ntawv thiab kev tswj xyuas tus neeg muag khoom Xav tau cov khoom tshwj xeeb thiab daim ntawv pov thawj, kev pom zoo ntawm tus neeg muag khoom tswj, kev tshuaj xyuas tuaj, kev sib cais ntau, thiab txheej txheem rau kev hloov pauv lossis hloov cov khoom siv.
- Kev soj ntsuam kev tsim muaj peev xwm Paub meej tias machining, forging, kev kho cua sov, vuam, polishing, passivation, txheej, sib dhos, thiab tshuaj xyuas muaj peev xwm ua tau raws li cov khoom. Txiav txim siab seb cov kauj ruam twg yog outsourced thiab yuav tswj lawv li cas.
- Tshawb xyuas cov txheej txheem validation thiab calibration Nug seb cov txheej txheem tshwj xeeb raug siv tau li cas thiab kev soj ntsuam, torque, qhov ntev, hluav taws xob, thiab lwm yam khoom siv ntsuas tau ntsuas thiab tswj li cas.
- Kuaj traceability thiab tswj cov ntaub ntawv Xaiv cov qauv ntau thiab nug cov chaw tsim khoom kom taug qab nws rov qab rau cov khoom siv raw, cov neeg taug kev lossis cov ntaub ntawv taug kev, kev tshuaj xyuas, kev tsis sib haum xeeb, daim ntawv lo, ntim khoom, thiab tso cai tso tawm.
- Ntsuas cov kev ua tau zoo thiab kev siv tau Pom zoo cov qauv tiv thaiv kev kos duab thiab siv cov txheej txheem xws li haum, sib dhos, tuav, txiav kev ua tau zoo, kev sib kis ntawm lub zog, kev sib txuas sib txuas, ergonomics, thiab rov ua dua.
- Kev tshuaj xyuas kev tu, ntim khoom, thiab kev ua kom tsis muaj menyuam Lub luag haujlwm Qhia meej seb cov khoom siv puas yog cov khoom siv tsis muaj menyuam tsis muaj menyuam lossis tsis muaj menyuam, tog twg tau lees paub kev tu thiab ua kom tsis muaj menyuam, thiab qhov kev ntim khoom zoo li cas, txee lub neej, bioburden, thiab cov ntaub ntawv pov thawj siv.
- Ntsuam xyuas kev tsim thiab kev tswj hwm rau kev ua haujlwm OEM / ODM, tshuaj xyuas cov khoom tsim tawm, kev tswj hwm kev pheej hmoo, kev kos duab, kev lees paub, kev siv tau, cov cuab yeej txawj ntse, kev pom zoo qauv, kev hloov tsim qauv, thiab kev hloov pauv-tswj lub luag haujlwm.
- Ntsuas lub peev xwm thiab kev cia siab rau kev xa khoom Tshawb xyuas lub sijhawm ua haujlwm tiag tiag, muaj peev xwm txwv tsis pub muaj, yam tsawg kawg nkaus kev txiav txim, kev ruaj ntseg Tshuag, kev kwv yees tuav, kev txiav txim kom paub meej, ntim qhov tseeb, cov ntaub ntawv xa tawm, thiab cov phiaj xwm rov qab rau qeeb.
- Txheeb xyuas cov lus tsis txaus siab, CAPA, warranty, thiab txuas ntxiv Paub meej tias qhov kev tsis txaus siab nce ntxiv, kev soj ntsuam hauv paus, kev kho thiab tiv thaiv, kev nqis tes ua lossis kev txhawb nqa rov qab, cov khoom seem, kho, cov lus lav, thiab kev lag luam txuas ntxiv.
Yuav Ua Li Cas Txheeb Xyuas Cov Cai Zoo thiab Kev Cai Lij Choj
ISO 13485 yog cov txheej txheem zoo
TS EN ISO 13485 Kev tswj hwm kev tswj hwm zoo rau cov koom haum koom nrog hauv kev kho mob-kwv yees lub neej. Nws yog cov ntaub ntawv pov thawj tseem ceeb thaum daim ntawv pov thawj siv tau thiab nws cov peev txheej suav nrog lub koom haum, qhov chaw, thiab kev ua ub no. Nws tsis yog, ntawm nws tus kheej, ua pov thawj tias txhua yam khoom hauv ib phau ntawv teev npe, kho kom haum, lossis tso cai hauv koj lub khw.
Nug kom tiav daim ntawv pov thawj es tsis yog lub logo cropped. Tshawb xyuas nws nrog lub cev ntawv pov thawj lossis nws cov ntaub ntawv pej xeem yog qhov ua tau, thiab sib piv lub tuam txhab npe thiab chaw nyob tiv thaiv cov lus hais, cov ntawv xa nyiaj, cov lus tshaj tawm, cov ntawv sau, thiab cov ntaub ntawv cov khoom.
Cov cim CE yuav tsum raug muab tso rau hauv lub cuab yeej thiab EU MDR txoj kev
Rau European Union, txiav txim siab txog kev faib cov cuab yeej thiab siv tau raws li txoj hauv kev-kev soj ntsuam raws li Txoj Cai Kho Mob. Txheeb xyuas EU Daim Ntawv Tshaj Tawm Txog Kev Ua Raws Cai thiab, thaum cov chav kawm xav tau kev ceeb toom-lub cev kev koom tes, daim ntawv pov thawj siv tau thiab ceeb toom-lub cev cov ntsiab lus. Paub meej tias tsev neeg cov khoom, cov chaw tsim khoom raug cai, Basic UDI-DI qhov tsim nyog, lub hom phiaj npaj, thiab daim ntawv pov thawj scope dlhos.
Kev sau npe ntawm FDA tsis yog FDA pom zoo
FDA tau hais meej meej tias kev tso npe ntawm cov chaw tsim khoom thiab cov npe khoom siv tsis qhia txog kev pom zoo, tshem tawm, lossis kev tso cai. Rau Tebchaws Meskas, txheeb xyuas cov cuab yeej kev faib tawm thiab seb lub cuab yeej puas xav tau 510(k) tshem tawm, kev pom zoo PMA, kev tso cai De Novo, lossis raug zam. Tshawb xyuas cov ntaub ntawv tseem ceeb ntawm cov ntaub ntawv tsis yog kev cia siab ntawm 'FDA sau npe' paib.
| Cov ntaub ntawv lossis thov | dab tsi los kuaj xyuas | Qhov nws tsis ua pov thawj ib leeg |
|---|---|---|
| ISO 13485 daim ntawv pov thawj | Lub npe raug cai, qhov chaw, thaj tsam, tus tsim tawm, kev lees paub, xwm txheej, thiab tas sij hawm. | Cov khoom lag luam tshwj xeeb kev tso cai los yog kev kho mob tsim nyog. |
| CE cim / EU cov ntaub ntawv | Cov cuab yeej yog tus kheej, kev faib tawm, kev tshaj tawm, ceeb toom lub cev yog qhov tsim nyog, thiab MDR kev pab them nqi. | Kev tso cai sab nraum lub koom haum European siv. |
| FDA tso npe / npe | Tam sim no tsim thiab sau cov ntaub ntawv ntxiv rau cov cuab yeej siv txoj kev tswj hwm. | FDA pom zoo, tshem tawm, kev tso cai, lossis kev pom zoo ywj pheej. |
| Daim ntawv xeem | Kev lees paub lub chaw kuaj mob uas cuam tshuam, qauv tus kheej, txoj hauv kev, kev lees paub, hnub tim, thiab qhov tshwm sim. | Tias txhua qhov ntau lawm yog zoo ib yam rau cov qauv kuaj. |
| Daim ntawv pov thawj ntawm kev txheeb xyuas / kev sib raug zoo | Ntau cov ntaub ntawv tshwj xeeb, cov lus qhia tshwj xeeb, cov txiaj ntsig, tso cai tso cai, thiab cov cim qhia tau zoo. | Kev ua tau zoo ntawm tag nrho cov txheej txheem zoo yam tsis muaj kev txhawb nqa cov ntaub ntawv. |
Koj Yuav Tsum Saib Xyuas Dab Tsi Thaum Lub Hoobkas lossis Kev Ntsuam Xyuas Zoo?
Kev pheej hmoo txiav txim siab tshawb xyuas qhov tob. Ib qho cuab yeej uas pheej hmoo tsawg tuaj yeem raug soj ntsuam los ntawm cov ntaub ntawv, kev soj ntsuam video nyob, thiab kuaj cov qauv. Ib qho kev cog lus tshiab-tshaj tawm cov cuab yeej, cov cuab yeej tsis muaj menyuam, cov txheej txheem tseem ceeb tshaj tawm, lossis cov kev pabcuam ntiag tug mus sij hawm ntev tuaj yeem ua pov thawj rau qhov kev tshuaj xyuas ntawm qhov chaw thiab siv tau ntau dua.
Kev tshawb xyuas muaj txiaj ntsig ua raws li qhov kev txiav txim tiag tiag lossis ntau los ntawm qhov chaw. XC Medico Kev tswj xyuas zoo thiab kev tshuaj xyuas cov txheej txheem muab ib qho piv txwv ntawm cov txheej txheem cov neeg yuav khoom tuaj yeem nug kom pom.
| Tshawb xyuas cheeb tsam | Pov thawj kom thov | Piv txwv lo lus nug |
|---|---|---|
| Cov khoom xa tuaj | Pom zoo cov npe khoom muag, daim ntawv pov thawj khoom siv, kev tshuaj xyuas tuaj, thiab cov ntaub ntawv cais tawm. | Yuav ua li cas yog cov ntaub ntawv ntau txuas mus rau cov twj tiav lawm? |
| Kev tswj ntau lawm | Cov lus qhia ua haujlwm, cov ntaub ntawv sau tseg, cov txheej txheem siv tau, cov neeg ua haujlwm tsim nyog, thiab kev tshuaj xyuas hauv cov txheej txheem. | Yuav ua li cas deviations nrhiav tau thiab muaj? |
| Kev ntsuas | Calibration xwm txheej, ntsuas txoj kev, ntsuas lub peev xwm, thiab cov ntaub ntawv soj ntsuam. | Lub ntsuas qhov kam rau ua ntsuas tau ntseeg tau? |
| Cov khoom tsis sib xws | Segregation, tso cai tso cai, rov ua haujlwm pom zoo, thiab cov ntaub ntawv sib txawv. | Leej twg tuaj yeem pom zoo rau qhov sib txawv, thiab yog tus neeg siv khoom ceeb toom? |
| Hloov tswj | Kev hloov kho keeb kwm, kev ntsuas cuam tshuam, kev txheeb xyuas, kev lees paub, thiab kev ceeb toom rau cov neeg siv khoom. | Cov kev hloov pauv twg yuav tsum tau sau ntawv tso cai rau tus neeg yuav khoom? |
| Traceability | Cov ntaub ntawv ntau lossis serial tooj cov ntaub ntawv, cov neeg taug kev, daim ntawv lo, ntim, thiab tso pov thawj. | Ib qho khoom tiav tuaj yeem taug qab hauv ob qho tib si? |
| Kev tsis txaus siab thiab CAPA | Cov ntaub ntawv tsis txaus siab, cov txheej txheem hauv paus hauv paus, CAPA kev kuaj xyuas ua tau zoo, thiab cov cai nce ntxiv. | Yuav txheeb xyuas thiab tiv thaiv li cas? |
Yuav ua li cas validate Surgical Instrument Samples
Ib qho qauv polished tsis txaus. Tsim ib daim qauv sau ntawv pom zoo uas qhia txog cov cuab yeej siv thiab kev pheej hmoo. Cov chaw tsim khoom thiab cov neeg yuav khoom yuav tsum pom zoo rau cov duab kos, qib kev kho dua tshiab, cov qauv kev xeem, cov qauv kev lees paub, cov qauv kom muaj nuj nqis, thiab cov qauv pom zoo li cas los ua tus tswv tsim khoom.
- Daim Ntawv Pov Thawj: qauv, kos duab kho, sab, loj, cim, ntau, thiab ntim khoom.
- Dimensions thiab interfaces: qhov tseem ceeb qhov ntev, mating qhov chaw, implant los yog ntsia hlau compatibility, runout, alignment, thiab tolerances.
- Khoom siv thiab ua tiav: qib, hardness, deg mob, corrosion kuj nyob qhov twg, passivation, txheej, thiab huv.
- Muaj nuj nqi: tuav, ratchet kev koom tes, txiav los yog drilling tus cwj pwm, torque kis tau tus mob, xauv, tso, thiab hnav.
- Reprocessing: tsis kam mus rau lub hom phiaj tu thiab kom tsis muaj menyuam, nrog rau cov pob qij txha, lumens, cov cim, txheej, thiab cov leeg.
- Ntim thiab daim ntawv lo: suav, kev tiv thaiv, kev txheeb xyuas, cov lus qhia, hom lus, UDI lossis ntau cov ntaub ntawv uas siv tau, thiab kev thauj mus los.
Repeatability check: tom qab cov qauv golden tau pom zoo, tshuaj xyuas cov qauv los ntawm thawj qhov ntau lawm siv tib cov qauv. Qhov no yuav pab txiav txim seb tus neeg tsim khoom puas tuaj yeem tsim cov qauv tsim tawm ntawm qhov ntsuas.
Kev ntsuam xyuas OEM thiab kev cai ntsuas peev xwm
Customization tuaj yeem txhais tau tias lub logo ntawm lub tais uas twb muaj lawm, hloov kho, lub cuab yeej tshwj xeeb rau kev cog ntoo, lossis cov cuab yeej tshiab kiag li. Cov phiaj xwm no tsis ua tib yam kev tswj hwm lossis kev tsim vaj tsev txaus ntshai. Ua ntej sib koom cov duab kos lossis cov qauv, txheeb xyuas qhov tsis pub lwm tus paub, tsim tswv cuab, tso cai siv cov cuab yeej cuab tam keeb kwm yav dhau, cov cuab yeej ua tswv cuab, thiab nkag mus rau cov ntaub ntawv pov thawj.
Rau ib daim ntawv teev npe ntiag tug lossis kev cai, tshuaj xyuas cov chaw tsim khoom orthopedic OEM / ODM muaj peev xwm thiab nug leej twg yog tus tswv ntawm txhua qhov kev tsim-tswj kev ua haujlwm. Tus neeg muag khoom muaj peev xwm yuav tsum txhais cov neeg siv cov kev xav tau rau hauv cov kev tswj hwm thiab cov ntaub ntawv hloov pauv - tsis txhob cia siab rau cov lus tsis raug lossis cov qauv tsis pom zoo.
| Customization theem Hom | Scope Yam | tsawg kawg nkaus yuav tsum tau tswj |
|---|---|---|
| Branding | Logo, daim ntawv lo, thawv, cov duab kos, thiab cov lus qhia. | Kev pom zoo kos duab, kev tshuaj xyuas daim ntawv lo, kev tswj xyuas kev kho dua tshiab, thiab kev txheeb xyuas kev lag luam. |
| Kev teeb tsa | Teeb muaj pes tsawg leeg, tais layout, qhov ntau thiab tsawg, thiab ntau. | Pom zoo daim nqi ntawm cov ntaub ntawv, tshuaj xyuas kev sib raug zoo, suav txheeb xyuas, thiab cov npe ntim khoom. |
| Cov khoom hloov kho | Dimensions, kov, interface, khoom, tiav, los yog muaj nuj nqi. | Kev soj ntsuam kev pheej hmoo, kev pom zoo kos duab, kev txheeb xyuas, kev lees paub qhov xav tau, thiab kev hloov pauv. |
| Kev tsim khoom tshiab | Lub tswv yim tshiab lossis ntsuas qhov system. | Kev tswj hwm kev tsim qauv, kev siv tau thiab kev tswj hwm kev pheej hmoo, kev tswj hwm lub tswv yim, kev txheeb xyuas, kev siv tau, thiab kev hloov tsim qauv. |
Ntim, Teem kom tiav, thiab Sterilization Compatibility
Cov cuab yeej siv tsis ua haujlwm thaum ib tus neeg cov cuab yeej ploj lawm, mislabeled, puas nyob rau hauv kev thauj mus los, incompatible with the implant, or hard to detect. Xav tau ib daim ntawv teev cov ntim khoom tswj thiab cov suav zaum kawg sib phim rau qhov chaw ntawm lub tais thiab ntsuas ntsuas. Rau cov tshuab siv rov siv tau, ntsuas cov dej ntws, ziab, disassembly, ntxuav kev nkag, qhov hnyav, tiv thaiv cov khoom ntse, thiab sib haum nrog cov txheej txheem kom tsis muaj menyuam.
Thaum lub thawv ntim rov qab siv tau yog ib feem ntawm lub kaw lus, tshuaj xyuas cov chaw tsim khoom sterilization ntim cov kev xaiv ua ke nrog rau lub chaw kho mob cov txheej txheem rov ua dua tshiab. Lub thawv lossis lub tais yuav tsum tsis txhob suav tias yog sib xws nkaus xwb vim tias cov cuab yeej siv lub cev haum rau hauv nws.
Ntsuas qhov muaj peev xwm, kev xa khoom, kev pabcuam, thiab tag nrho cov nqi
Tom qab cov kev cai thiab kev ua tau zoo tau ntsib, sib piv cov phiaj xwm kev lag luam. Nug kom muaj peev xwm thiab siab tshaj plaws, cov khoom siv raw khoom txwv, yam tsawg kawg nkaus txiav txim kom muaj nuj nqis, qauv coj mus kuaj, lub sij hawm ua cov khoom, cov kev cai forecast, Incoterms, export cov ntaub ntawv, packing method, thiab ncua sij hawm ceeb toom txheej txheem. Saib xyuas tus neeg muag khoom muab-chain thiab warehousing qauv , tom qab ntawd sim nws nrog cov pov thawj xws li cov ntaub ntawv xa tawm tsis ntev los no.
Tag nrho cov nqi ntawm cov tswv cuab suav nrog ntau tshaj tus nqi tsev:
- kev tsim nyog, kev sau npe, kev tshuaj xyuas, kev sim, thiab cov nqi siv tau;
- cov cuab yeej, artwork, ntim, kom tsis muaj menyuam, freight, dej num, thiab cov khoom muag;
- cov cuab yeej uas ploj lawm lossis puas lawm, kev hloov pauv sai, thiab kev cuam tshuam ntawm cov txheej txheem;
- kev txhim kho, khoom seem, kev pabcuam, kev lees paub tsis suav nrog, thiab kev tuav tsis txaus siab;
- tus nqi thiab kev pheej hmoo ntawm kev hloov cov khoom lag luam yog tias kev ua haujlwm tsis txaus ntseeg.
Ua ntej kev pom zoo, cov ntaub ntawv lub sij hawm teb, kev tsis txaus siab ua tswv, rov qab tso cai, cov ntaub ntawv tshawb fawb, kho lossis hloov txoj kev, thiab kev sib txuas lus nce ntxiv. XC Medico luam tawm nws tam sim no tom qab-muag thiab warranty txheej txheem rau cov neeg yuav tshuaj xyuas.
Piv txwv Surgical Instrument Manufacturer Scorecard
Tau qhab nia txhua qhov ntsuas los ntawm 0 mus rau 5, muab faib los ntawm qhov ntsuas qhov hnyav, thiab sau cov pov thawj tshuaj xyuas. Tsim kom muaj qhov yuav tsum tau hla / tsis ua haujlwm rau kev cai lij choj thiab kev tswj hwm kom cov qhab nia siab ua lag luam tsis tuaj yeem them rov qab rau kev ua raws li qhov tsis ua.
| Kev ntsuam xyuas cheeb tsam | pom tias hnyav | pov thawj | Pass rooj vag |
|---|---|---|---|
| Kev cai lij choj thiab kev cai raws li txoj cai | 15% | Cov ntaub ntawv lag luam, kev tso cai ua lag luam, cov npe khoom siv lossis kev tshem tawm raws li muaj. | Yuav tsum tau |
| Kev tswj hwm zoo | 15% | TS EN ISO 13485 Scope / xwm txheej, tshawb xyuas cov txiaj ntsig, cov txheej txheem, cov ntaub ntawv. | Yuav tsum tau |
| Technical thiab manufacturing muaj peev xwm | 20% | Khoom siv, txheej txheem, validation, tus neeg teb xov tooj, outsourced-txheej txheem tswj. | Yuav tsum tau ua kom tau |
| Cov qauv zoo thiab kev ua haujlwm zoo | 20% | Kev soj ntsuam daim ntawv tshaj tawm, kev sim ua haujlwm, kev sib raug zoo, kev ntsuas rov ua dua. | Yuav tsum tau |
| Traceability thiab hloov tswj | 10% | Ntau qhov kev tawm dag zog, cov ntaub ntawv kho dua tshiab, kev pom zoo rau cov neeg siv khoom. | Yuav tsum tau |
| Kev xa khoom thiab xa khoom txuas ntxiv | 10% | Muaj peev xwm, lub sijhawm ua khoom, keeb kwm kev xa khoom, kev ruaj ntseg Tshuag, phiaj xwm xwm txheej. | Qhov pib |
| Kev pabcuam thiab kev txhawb nqa lub neej | 5% | Kev tsis txaus siab/CAPA txheej txheem, warranty, kho, spare qhov chaw, escalation. | Qhov pib |
| Tag nrho cov nqi thiab cov nqe lus ua lag luam | 5% | Tus nqi tsaws, MOQ, kev them nqi, cuab yeej cuab tam, lav tsis suav nrog. | Qhov pib |
Khaws daim ntawv teev cov qhab nia ua tiav hauv cov ntaub ntawv xa khoom, txheeb xyuas cov haujlwm qhib thiab cov tswv, thiab teeb tsa lub sijhawm rov ntsuas dua raws li kev pheej hmoo thiab kev ua haujlwm. Saib xyuas cov khoom tsis zoo, kev tsis txaus siab, kev kho kom raug, kev xa khoom, kev teb, thiab kev hloov pauv tsis tau tso cai tom qab pom zoo.
Common Supplier Red Flags
Tshawb nrhiav XC Medico's Manufacturing Scope
Cov peev txheej sab hauv no tuaj yeem pab txhawb kev txheeb xyuas kev muaj peev xwm. Cov neeg yuav khoom tseem yuav tsum txheeb xyuas cov ntaub ntawv thiab cov khoom tsim nyog rau lawv tus kheej lub khw thiab npaj siv.
Cov lus nug nquag
Dab tsi yog daim ntawv pov thawj tseem ceeb tshaj plaws rau cov chaw tsim khoom siv phais?
Tsis muaj ib daim ntawv pov thawj thoob ntiaj teb uas pom zoo rau txhua tus neeg tsim khoom thiab cov khoom lag luam. ISO 13485 yog ib qho tseem ceeb ntawm kev kho mob-cov cuab yeej zoo-txheej txheem txheej txheem, tab sis cov neeg yuav khoom yuav tsum tau txheeb xyuas cov khoom tshwj xeeb cov kev cai rau lub khw muag khoom thiab daim ntawv pov thawj txoj haujlwm thiab siv tau.
Puas yog FDA tso npe txhais tau tias cov cuab yeej phais tau pom zoo FDA?
Tsis yog. FDA tso npe thiab npe khoom siv tsis tau txhais hais tias lub chaw lossis cov cuab yeej raug pom zoo, tshem tawm, lossis tso cai. Txheeb xyuas qhov kev faib khoom siv tiag tiag thiab siv tau FDA txoj kev tswj hwm.
Puas yog tus neeg yuav khoom ib txwm ua qhov kev tshuaj xyuas ntawm lub Hoobkas?
Tsis tas li. Kev tshawb xyuas qhov tob yuav tsum muaj kev pheej hmoo. Kev tshuaj xyuas cov ntaub ntawv, kev soj ntsuam video nyob, cov qauv, thiab cov pov thawj thib peb yuav txaus rau qee qhov kev yuav khoom qis dua. Muaj kev pheej hmoo siab dua, tsis muaj menyuam, kho kom haum, tseem ceeb, lossis kev npaj khoom siv mus sij hawm ntev tuaj yeem ua pov thawj rau kev tshawb xyuas ntawm qhov chaw.
Muaj pes tsawg tus qauv yuav tsum tau soj ntsuam?
Qhov ntau yog nyob ntawm kev pheej hmoo ntawm cov cuab yeej, kev hloov pauv, txoj kev sim, thiab kev txiav txim loj. Ntsuam xyuas cov units txaus los ntsuas qhov loj me thiab kev ua haujlwm, tom qab ntawd txheeb xyuas qhov rov ua dua dua siv thawj qhov ntau lawm.
Cov cuab yeej phais puas tuaj yeem hloov kho rau daim ntawv lo ntiag tug?
Yog lawm, tab sis kev tsim khoom lag luam, teeb tsa kev teeb tsa, hloov khoom lag luam, thiab kev tsim cov khoom tshiab yuav tsum muaj ntau theem ntawm cov ntaub ntawv thiab kev tswj hwm. Txhais kev tsim tswv cuab, kev txheeb xyuas, sau npe lub luag haujlwm, kev hloov pauv, thiab kev tso cai ua lag luam ua ntej pib.
Ntev npaum li cas tus neeg tsim khoom pom zoo yuav tsum rov ntsuas dua?
Teem lub sijhawm raws li kev pheej hmoo thiab kev ua haujlwm tiag tiag. Kev tsis xws luag, kev tsis txaus siab, kev xa khoom tsis ua tiav, kev hloov pauv loj, kev hloov pauv daim ntawv pov thawj, lossis cov teeb meem kho kom raug yuav ua rau muaj kev tshuaj xyuas ua ntej lossis kev tshuaj xyuas.
Xaus
Kev ntsuam xyuas cov chaw tsim khoom tau zoo hloov cov lus thov kev lag luam rau hauv cov ntaub ntawv pov thawj. Txhais cov kev xav tau, txheeb xyuas cov ntaub ntawv raug cai thiab kev tswj hwm, taug qab ntau qhov tiag, kuaj cov qauv tiv thaiv kev pom zoo, thiab tshuaj xyuas cov kev tswj hwm uas ua rau yav tom ntej kev tsim khoom zoo ib yam. Daim ntawv teev cov qhab nia ua rau cov neeg siv khoom txiav txim siab yooj yim dua los tiv thaiv thiab muab cov hauv paus rau kev saib xyuas kev ua haujlwm tsis tu ncua.
Cov ntaub ntawv pov thawj
- International Organization for Standardization: ISO 13485-Kev kho mob cov cuab yeej tswj kev tswj kom zoo.
- US FDA: FDA tso npe tiv thaiv cov cuab yeej pom zoo, tshem tawm, lossis kev tso cai.
- US FDA: Yuav ua li cas kawm thiab ua lag luam khoom siv kho mob.
- European Commission: Cov cai tswj kev kho mob thiab cov chaw tsim khoom lag luam.
