Thaum cov neeg muag khoom pib nrhiav OEM cov chaw tsim khoom orthopedic, lawv feem ntau pib nrog Google tshawb nrhiav, cov npe ntawm cov lus nug, thiab daim ntawv tshuaj xyuas kev puas siab puas ntsws. TS EN ISO 13485 - Kev kuaj xyuas. FDA 510 (k) - xyuas. Nqe sib tw - kos.
Txog thaum lawv paub tias tsis ua haujlwm, lawv twb tau kaw lawm. Tej zaum nws yog lub hli yim thiab lawv tseem tos cov khoom xa tuaj. Tej zaum cov nroj tsuag txiav txim siab tso tseg kev tsim khoom los ua haujlwm hauv tsev kho mob loj dua daim ntawv cog lus. Los yog tej zaum lawv tau txais lawv thawj qhov kev soj ntsuam xyuas thiab pom cov chaw tsim khoom cov ntaub ntawv yog kev puas tsuaj.
Qhov no tsis yog hais txog kev txheeb xyuas cov ntawv pov thawj. Nws yog hais txog kev nkag siab txog qhov ua tau zoo rau koj txoj kev koom tes rau 3 txog 5 xyoos tom ntej - thiab cov lus nug dab tsi uas cov neeg muag khoom feem ntau tsis nco qab nug.
Qhov sib txawv tiag tiag ntawm tus neeg muag khoom thiab tus khub OEM
Ua ntej, ib qho kev qhia meej uas tseem ceeb tshaj qhov nws yuav tsum tau: hu rau ib tus neeg ua 'OEM chaw tsim khoom' tsis txhais tau tias lawv tsim khoom tiag tiag. Qee tus neeg muag khoom hauv Suav teb yuav cog cog los ntawm ib lub Hoobkas, npuaj koj lub logo ntawm lub ntim, thiab xa tuaj rau koj. Qhov ntawd yog rebranding. Nws yog private labeling. Nws yog pheej yig dua, sai dua, tab sis nws tsis yog OEM.
Tus neeg koom tes OEM tiag tiag tswj cov tswv yim tsim. Lawv ua haujlwm nrog koj cov lus qhia tshwj xeeb - txawm tias koj tab tom thov kom lawv hloov kho qhov system uas twb muaj lawm lossis tsim ib yam tshiab. Lawv tuav cov ntaub ntawv tswj hwm hauv lawv lub npe, sawv cev rau koj. Lawv muab cov ntaub ntawv batch nrog koj lub npe. Lawv sawv tom qab cov khoom los ntawm kev soj ntsuam tom qab kev lag luam.
Yog vim li cas qhov kev sib txawv no tseem ceeb yog kev lav ris. Yog hais tias tus distributor private-labels implants los ntawm ib tug rebrander, thiab ib yam dab tsi mus tsis ncaj ncees lawm nyob rau hauv lub teb, tus distributor yog lub luag hauj lwm rau qhov kho. Lub rebrander twb tau txiav lawv. Tus khub OEM, los ntawm daim ntawv cog lus, sib koom ua haujlwm zoo - uas txhais tau hais tias lawv mob siab rau koj txoj kev vam meej.
Yog li thawj lo lus nug ua ntej tham nrog leej twg: Puas yog lawv tsim khoom tiag tiag, lossis lawv puas muag nrog koj daim ntawv lo rau nws?
Daim ntawv pov thawj lo lus nug yog qhov nyuaj tshaj qhov nws zoo li
Txhua qhov chaw tsim khoom thov ISO 13485. Qhov teeb meem yog qhov dav. Lub Hoobkas tej zaum yuav yog ISO 13485 ntawv pov thawj rau daim hlau raug mob tab sis tsis yog rau cov leeg txha caj qaum. Los yog lawv tuaj yeem tuav CE cim rau Tebchaws Europe tab sis tsis muaj FDA tshem tawm rau Asmeskas. Los yog lawv tau ntawv pov thawj rau cov khoom lag luam tab sis tsis yog rau cov qauv tsim.
Peb tau pom cov neeg muag khoom kos npe rau daim ntawv cog lus nrog cov neeg tsim khoom uas zoo li kev ntseeg siab ntawm daim ntawv, tsuas yog ntaus thawj txoj cai tseem ceeb thiab nrhiav pom cov nroj tsuag cov ntaub ntawv kev coj ua tsis zoo rau cov ntawv pov thawj. Cov neeg tshawb xyuas tsis quav ntsej txog daim ntawv pov thawj hais tias - lawv saib xyuas dab tsi hauv cov ntaub ntawv tiag tiag. Thiab yog tias lub Hoobkas tau txiav cov ces kaum ntawm cov ntaub ntawv kom txuag tau sijhawm, qhov ntawd tshwm sim sai.
Qhov tseem ceeb yog dab tsi: Nug kom pom daim ntawv pov
thawj daim ntawv txuas ntxiv - cov ntaub ntawv uas teev raws nraim cov khoom thiab cov txheej txheem tau lees paub. Nug lub teb chaws twg lawv tau sau npe muag cov cog cog hauv, thiab thov lawv cov lej sau npe. Yog tias lawv tsis tuaj yeem tsim qhov no hauv 48 teev, txav mus.
Kuj nug: Thaum twg yog koj qhov kev tshuaj xyuas zaum kawg? Cov kev tshawb pom yog dab tsi? Feem ntau yuav tsis tuaj yeem pab dawb cov txiaj ntsig tsis zoo, tab sis yog tias lawv tau tiv thaiv cov lus nug, qhov ntawd yog lub teeb liab.
Rau Tuam Tshoj-based manufacturers, muaj ib daim ntawv pov thawj ntxiv uas tseem ceeb yog tias koj muag rau hauv Teb Chaws Asmeskas: MDSAP (Medical Device Single Audit Program). Ib daim ntawv pov thawj no suav nrog FDA, Canada, Nyiv, thiab Brazil. Nws yog kim thiab siv sij hawm kom tau. Yog tias lub Hoobkas suav muaj nws, lawv tau nqis peev nyiaj loj hauv kev ua raws cai. Nws tsis yog qhov lav, tab sis nws yog lub teeb liab muaj zog dua li ISO 13485 ib leeg.
Qhov kev sib tw yog tias cov khoom sib txawv feem ntau xav tau cov ntawv pov thawj sib txawv. Koj txoj kab kev raug mob yuav raug FDA tshem tawm thaum koj cov kab mob txha caj qaum tseem nyob hauv CE nkaus xwb. Thaum ntsuas cov tuam txhab tsim khoom, xyuas seb lawv puas tuaj yeem npog cov khoom tshwj xeeb uas koj npaj yuav faib - koj tuaj yeem tshuaj xyuas lawv. kev raug mob implant systems thiab spine implant khoom kab kom nkag siab tias daim ntawv pov thawj zoo li cas nrog cov khoom siv tiag tiag.
Zaj Dab Neeg Xa Lawv Qhia Koj vs. Kev Xa Koj Yuav Tau Txais
Txhua tus neeg tsim khoom hais tias lawv muaj kev xa khoom sai. '3 hnub rau cov khoom Tshuag, 30 hnub rau kev txiav txim.' Tab sis qhov ntawd txhais tau li cas?
Peb hnub txij thaum twg? Los ntawm lub sij hawm lawv tau txais koj daim ntawv yuav khoom thiab them nyiaj clears? Los yog los ntawm lub sijhawm cov khoom xa tuaj tawm ntawm lawv qhov chaw? Thiab 'cov khoom lag luam' - puas yog cov khoom uas lawv khaws cia hauv cov khoom muag, lossis cov khoom lawv tuaj yeem ua tau sai? Cov no yog cov lus txhob txwm tsis meej pem.
Nov yog qhov peb tau pom: cov tuam txhab lag luam nrog cov xa khoom sai sai khaws cov khoom lag luam siab (feem ntau 80% + ntawm lawv cov SKU catalog hauv Tshuag). Qhov ntawd raug nqi lawv cov nyiaj ntsuab thiab chaw khaws khoom, yog li lawv tsuas yog ua nws yog tias lawv tau txiav txim siab tias yog tus qauv ua lag luam. Cov chaw tsim khoom uas thov kev hloov pauv sai tab sis muaj cov khoom muag qis yog dag lossis lawv yuav thawb koj qhov kev txiav txim rov qab thaum tus neeg siv khoom loj tuaj nrog.
Qhov teeb meem thib ob yog kev sib txuas lus. Lub chaw tsim khoom tuaj yeem xa khoom raws sijhawm tab sis tsis txhob qhia koj thaum nws xa khoom. Koj kawm los ntawm kev taug qab tus lej peb lub lis piam tom qab. Thaum muaj kev ncua, koj tsis hnov dab tsi txog thaum koj caum lawv. Qhov no tseem ceeb vim tias koj lub tsev kho mob tos. Yog tias koj tsis tuaj yeem qhia koj cov neeg siv khoom thaum twg cov khoom cog yuav tuaj txog, qhov ntawd yog teeb meem kev lag luam.
Nug rau cov ntaub ntawv siv. Hu rau ib tus ntawm lawv lwm tus neeg xa khoom thiab nug: 'Thaum koj tab tom tos cov khoom xa tuaj, lub Hoobkas puas qhia koj cov xwm txheej hloov tshiab, lossis koj puas yuav tsum nug?' Koj yuav kawm ntau yam los ntawm cov lus teb.
Kuj nug lawv tus nqi xa khoom raws sij hawm rau 12 lub hlis dhau los. Tus neeg tsim khoom ncaj ncees yuav hais qee yam zoo li 92%. Yog tias lawv hais 100%, lawv yog cov tshiab lossis lawv tab tom qhia koj qhov koj xav hnov.
Khoom Zoo thiab Traceability - qhov twg tus nqi siab tau txais tiag
Qhov no yog qhov uas ciam teb ntawm 'zoo txaus' thiab 'kev nyab xeeb tiag' tau fuzzy, thiab qhov twg tus nqi siab thawb cov tuam txhab mus rau hauv cov ces kaum.
Orthopedic implants yog tsim los ntawm titanium alloy, stainless hlau, los yog cobalt-chromium. Cov khoom siv tshwj xeeb: ASTM F136 (ntxiv-qis interstitial titanium) raug nqi ntau dua ASTM F67 (kev lag luam ntshiab titanium), tab sis nws muaj kev qaug zog zoo dua. Lub chaw tsim khoom cog lus rau qhov zoo siv qhov zoo spec rau daim ntawv thov. Lub chaw tsim khoom nyob rau hauv tus nqi siab siv txhua yam dhau los soj ntsuam.
Tab sis ntawm no yog cov lus nug nyuaj dua: Koj ua li cas thiaj paub tseeb cov khoom zoo? Cov ntaub ntawv pov thawj los ntawm cov khoom siv raw khoom tsis txaus. Koj xav tau cov ntawv ceeb toom kev sim ntsuas - kev sim qaug zog, lub zog tensile, hardness - ib qho ntau. Thiab koj xav tau lawv archived tsawg kawg yog 3 xyoo nyob rau hauv cov ntaub ntawv ib yam khoom tsis ua hauj lwm thiab koj xav tau cov ntaub ntawv forensic.
Nug ib lub chaw tsim khoom: 'Koj puas muaj chaw kuaj hauv tsev?' Yog tias cov lus teb tsis yog, lawv tau xa cov qauv mus rau lwm tus neeg sab nrauv. Qhov ntawd qeeb dua thiab kim dua rau lawv, uas txhais tau tias tsawg dua cov khoom tau sim. Yog lawv hais tias yog, nug seb lawv muaj dab tsi. Lub tshuab Instron rau kev ntsuas tensile, TA tshuab rau kev sim qaug zog, CMM rau kev txheeb xyuas qhov ntev - cov no yog $ 100K + txhua. Yog tias lub Hoobkas tau nqis peev ntau npaum li ntawd hauv kev sim, lawv ua qhov zoo tiag tiag.
Kuj nug txog traceability. Lawv puas tuaj yeem taug qab txhua qhov cog rov qab rau nws cov khoom siv raw? Txhua tus ntsia hlau yuav tsum muaj tus lej cim laser. Thaum koj rub cov ntsia hlau los ntawm cov khoom muag rau lub hlis txij li tam sim no, lawv puas tuaj yeem tsim cov ntawv tshaj tawm kev sim tshuab los ntawm cov khoom uas nws tuaj? Yog tias tsis yog, koj muaj teeb meem kev tswj hwm yog tias muaj dab tsi ua tsis tiav.
Yog tias koj xav tau los ntsuas cov khoom tshwj xeeb thiab cov ntaub ntawv pov thawj, cov tuam ntxhab uas muab cov ncauj lus nthuav dav feem ntau muab rub tawm. Cov khoom lag luam tshwj xeeb thiab cov ntaub ntawv thev naus laus zis - qhov no yog ib txoj hauv kev los ntsuam xyuas seb lawv cov kab lis kev cai ua tau raws li koj cov kev xav tau ntawm kev lag luam.
Tus nqi zais ntawm OEM Flexibility
Ntau tus neeg xa khoom xav tias OEM kev tsim khoom txhais tau tias lawv tuaj yeem thov kev hloov kho thaum twg lawv xav tau. Qhov sib txawv me ntsis ntawm lub phaj. Ib qho xim sib txawv rau kev kos. Ib lub thawv tsim uas phim lawv lub npe.
Nov yog qhov teeb meem: Txhua qhov kev hloov kho yuav tsum muaj kev tsim qauv siv tau, cov ntaub ntawv hloov kho tshiab, thiab cov nqi siv tshiab. Cov tuam txhab lag luam feem ntau yuav zoo siab coj koj qhov kev txiav txim rau kev hloov kho kev cai - ntawm 3x tus nqi ntawm cov khoom lag luam, nrog rau 90-hnub txhuas lub sijhawm. Tus neeg xa khoom xav tias yuav tshaj tawm cov khoom lag luam ntiag tug tshiab thiab pom tias lawv tau cog lus rau $ 50K hauv cov nqi siv cuab yeej thiab lub sijhawm tswj hwm rau lub hlis.
Qhov no yog vim li cas koj yuav tsum paub meej txog dab tsi 'OEM' txhais tau tias hauv koj daim ntawv cog lus. Yog tias koj xav tau kev tsim qauv yooj yim, koj xav tau:
- Cov lus qhia meej txog qhov kev hloov pauv twg yog pub dawb (khoom noj khoom haus: ntim, ntawv lo)
- Qhov kev hloov kho twg yuav tsum tau them nqi ntxiv thiab ncua sij hawm (tsim kev hloov pauv: cov ces kaum, qhov ntev)
- Leej twg yog tus tswv tsim ib zaug tsim (koj lossis lawv?)
- Yuav ua li cas yog tias koj xav coj tus qauv mus rau lwm lub chaw tsim khoom tom qab
Kuj nug: Dab tsi yog lawv qhov kev txiav txim yam tsawg kawg nkaus rau cov qauv tsim? Qee lub tuam txhab xav tau 1,000 units ua ntej lawv yuav khiav cov cuab yeej kev cai. Ib txhia yuav ua 200. Qhov txawv ntawd yog qhov tseem ceeb rau ib tug distributor tseem validating ib cov khoom tshiab.
Cov lus nug IP Tsis muaj leej twg xav tham txog
Ua haujlwm nrog cov chaw tsim khoom hauv Suav teb ua rau muaj kev txhawj xeeb txog IP raug cai. Tsis yog vim Suav cov chaw tsim khoom muaj qhov tsis ntseeg siab, tab sis vim tias cov qauv kev txhawb siab sib txawv. Yog tias koj tus khub OEM tsis tuaj yeem sib tw raws cai nrog koj hauv koj lub khw, lawv raug sim tsawg dua los txiav cov ces kaum lossis tsoo koj cov qauv tsim.
Daim ntawv cog lus yuav tsum muaj xws li:
- NDA Qhia meej - ua tiav ua ntej cov ntaub ntawv tsim lossis cov lus qhia tshwj xeeb tau muab qhia
- Ownership clause - cov lus qhia meej tias cov kev cai tsim tsim rau koj cov kev qhia tshwj xeeb tseem yog koj tus IP
- Kev tsis sib tw - txwv cov chaw tsim khoom los ntawm kev muab cov qauv OEM zoo ib yam rau koj cov neeg sib tw ncaj qha hauv koj thaj chaw sau npe
- Cov cai tshawb xyuas - txoj cai los tshuaj xyuas cov ntaub ntawv tsim khoom thiab cov ntaub ntawv zoo
Cov lus cog tseg ntawm cov ntsiab lus no tsis muaj nqis dab tsi. Yog tias cov chaw tsim khoom tsis kam muab cov lus tiv thaiv IP rau hauv daim ntawv cog lus, qhov kev tsis txaus siab yog qhia.
Qhov Kev Sib Raug Zoo Li Cas Tom Qab Kos Npe
Thaum daim ntawv cog lus tau kos npe, kev sib raug zoo yog txhais los ntawm peb yam:
Kev sib txuas lus zaus. Qee cov tuam ntxhab ua cov hloov tshiab txhua lub lim tiam. Ib txhia mus ntsiag to tshwj tsis yog koj caum lawv. Tsim kom muaj kev cia siab ua ntej: Koj puas yuav tau txais kev pom zoo ntawm cov khoom xa tuaj? Lub sij hawm teb rau cov lus nug ceev yog dab tsi? Lawv puas muaj tus thawj tswj hwm tus account tshwj xeeb lossis koj puas yog daim pib hauv kab?
Flexibility nrog kev txiav txim. Koj puas tuaj yeem thim qhov kev xaj xaj tom qab nws tso? Koj puas tuaj yeem txo qhov ntau yog tias koj daim ntawv cog lus hauv tsev kho mob hloov? Koj puas tuaj yeem nce qhov ntau yog tias xav tau spikes? Tau txais qhov no hauv kev sau ntawv. Qhov txawv ntawm 'koj tuaj yeem tshem tawm mus txog 14 hnub ua ntej xa khoom' thiab 'tsis muaj kev tshem tawm' yuav muaj teeb meem.
daws teeb meem. Yuav ua li cas yog ib batch tuaj txog thiab koj pom cov teeb meem zoo? Puas yog lawv hloov tam sim ntawd lossis xav kom koj xa cov qauv rov qab rau kev sim? Lawv puas them shipping? Puas muaj 30-hnub lub qhov rais los qhia txog qhov tsis xws luag lossis puas yog lub neej? Ntxiv dua thiab, qhov no yog nyob rau hauv daim ntawv cog lus, tab sis distributors feem ntau hla kev nyeem nws kom zoo.
Ib qho Kev Tshawb Fawb Yooj Yim
Ua ntej kos npe rau ib yam dab tsi, nug koj tus kheej: Yog tias kuv tsis xaj los ntawm cov chaw tsim khoom tag kis, lawv puas tseem teb kuv cov lus? Los yog lawv tsuas mob vim kuv tab tom xaj?
Kev sib raug zoo ntawm tus khub txhais tau tias lawv xav nyob hauv kev lag luam nrog koj. Kev sib raug zoo ntawm tus neeg muag khoom txhais tau tias lawv xav tau koj daim ntawv xaj tam sim no. Qhov sib txawv tshwm sim thaum koj xav tau kev txhawb nqa thiab lub Hoobkas tsis khoom nrog tus lej loj dua.
Nug rau tus account siv - lwm tus neeg xa khoom twb tau siv lawv. Hu rau tus neeg faib khoom ntawd thiab nug: 'Thaum koj muaj teeb meem, lawv teb li cas?' Koj yuav tau txais cov lus teb ncaj ncees. Cov neeg muag khoom feem ntau zoo siab tham txog lawv cov neeg muag khoom, tshwj xeeb tshaj yog tias lwm tus neeg ua raws li kev mob siab rau.
Thaum Koj Npaj Kom Mus Rau Hauv
Yog tias koj tab tom ntsuas OEM cov tuam txhab, tej zaum koj tab tom nrhiav kom nthuav koj cov khoom lag luam lossis koj tab tom hloov los ntawm tus neeg muag khoom uas tsis muaj kev ntseeg siab ntxiv lawm. Cov ceg txheem ntseeg yog tiag tiag - koj tab tom ua cov khoom muag, kev tswj hwm kev siv zog, thiab kev kho mob lub koob npe nrov rau qhov kev koom tes no.
Pib nrog kev muaj peev xwm: Lawv puas tuaj yeem tsim qhov koj xav tau? Lawv puas tuaj yeem ua raws li koj qhov yuav tsum tau ua? Lawv puas tuaj yeem ntsuas nrog koj txoj kev loj hlob? Tsuas yog tom qab cov ntawv lees paub yog tias koj sib tham tus nqi.
Tom qab ntawd txav mus rau kev ua haujlwm: lawv puas tuaj yeem ntseeg tau? Lawv puas yuav sib txuas lus? Lawv puas yuav daws teeb meem nrog koj thaum muaj teeb meem?
Yog tias koj tab tom txiav txim siab tiag tiag rau Tuam Tshoj-based OEM tus khub, cov kauj ruam tom ntej yog ntsuas tus qauv ua haujlwm thiab nkag siab txog lawv cov txheej txheem rau kev tuav cov ntim qis. Ntau tus neeg xa khoom xav tias OEM kev koom tes xav tau kev cog lus loj ua ntej - tab sis cov neeg tsim khoom lag luam nkag siab tias koj yuav tsum tau ua kom haum, cov ntaub ntawv, thiab kev lees paub kho mob ua ntej ntsuas cov khoom muag. Thaum koj npaj txhij los tham txog cov khoom lag luam tshwj xeeb thiab lub sijhawm xav tau, koj tuaj yeem pib sib tham nrog tus kws tshaj lij OEM kom nkag siab tias kev koom tes zoo li cas ntawm koj qhov kev loj hlob.
Cov nqe lus cog lus tseem ceeb, tab sis kev sib raug zoo muaj peev xwm tseem ceeb dua. Koj tsis yuav ib yam khoom. Koj tab tom yuav nkag mus rau tus neeg tsim khoom lag luam uas qhia koj txoj kev cog lus rau tus kws phais mob kev nyab xeeb thiab tsev kho mob ua tiav.
Nrhiav kev ntsuam xyuas OEM kev xaiv? Thov cov qauv, nug rau cov ntaub ntawv siv, thiab sib tham txog qhov kev sib koom tes zoo li cas.
Cov lus nug nquag nug
dab tsi yog qhov txawv ntawm OEM thiab ODM?
OEM txhais tau tias cov chaw tsim khoom tsim cov khoom cog rau koj cov kev qhia tshwj xeeb - koj tus qauv tsim, koj hom. ODM txhais tau tias lawv muab lawv tus kheej tsim uas koj tuaj yeem tso cai thiab daim ntawv ntiag tug raws li koj hom. ODM sai dua thiab pheej hmoo tsawg dua; OEM yog qhov tsim nyog thaum koj muaj cov cai tsim qauv lossis cov khoom lag luam uas twb muaj lawm IP los tiv thaiv.
Nws yuav siv sij hawm ntev npaum li cas thiaj tau txais OEM orthopedic cov khoom lag luam?
Rau ODM nrog cov qauv uas twb muaj lawm, 3-6 lub hlis yog qhov tseeb rau kev lag luam nrog CE lossis FDA-tawm cov ntaub ntawv uas twb muaj lawm. Rau tag nrho OEM nrog kev cai tsim, pob nyiaj siv 12-18 lub hlis los suav rau kev tsim qauv, kev tswj xyuas, thiab kev sau npe. Kev lag luam uas yuav tsum tau sau npe ntev hauv zos (xws li Brazil ANVISA, Tuam Tshoj NMPA) ntxiv sijhawm ntxiv.
Cov ntawv pov thawj dab tsi yuav tsum yog Tuam Tshoj-based OEM orthopedic chaw tsim khoom tuav?
Yam tsawg kawg nkaus: ISO 13485 nrog cov peev txheej uas npog koj cov khoom tshwj xeeb. Daim npav CE yuav tsum muaj rau kev lag luam nyob sab Europe; FDA 510 (k) tshem tawm rau Asmeskas; MDSAP xav tau ntau ntxiv rau Canada, Brazil, Australia, thiab Nyiv. Tsis txhob xav tias ib daim ntawv pov thawj npog tag nrho cov khoom lag luam - thov cov ntawv txuas ntxiv rau txhua daim ntawv pov thawj.
Dab tsi yog qhov tsim nyog MOQ rau private-label orthopedic implants?
MOQs sib txawv los ntawm cov chaw tsim khoom thiab cov khoom lag luam. Rau ib tus neeg muag khoom tsim cov kab ntawv ntiag tug tshiab, nrhiav cov neeg muag khoom muab SKU-theem MOQs nyob rau hauv thaj tsam ntawm 20-50 units rau thawj zaug xaj, nrog cov nqi ntim raws li qib rau kev xaj rov qab. Ceev faj ntawm cov tuam txhab lag luam uas xav tau daim pam ntim cov lus cog tseg thoob plaws tag nrho cov kab ke ua ntej koj tau txais kev pom zoo kho mob hauv koj lub khw.
Kuv yuav tiv thaiv kuv tus IP li cas thaum ua haujlwm nrog Suav chaw tsim khoom orthopedic?
Ua ib qho NDA ua ntej sib qhia cov qauv tsim, cov ntaub ntawv lag luam, lossis cov ntaub ntawv neeg siv khoom. Daim ntawv cog lus OEM nws tus kheej yuav tsum suav nrog cov lus qhia meej IP cov tswv cuab (kev cai tsim muaj rau koj), kev txwv tsis pub sib tw rau koj thaj chaw sau npe, thiab cov cai tshawb xyuas. Sau npe koj cov cim lag luam hauv Suav teb ua ntej pib tsim khoom - Suav lag luam txoj cai lij choj yog thawj-rau-cov ntaub ntawv, tsis yog thawj-rau-siv.
Lub tuam txhab OEM puas tuaj yeem muab cov ntaub ntawv tswj hwm rau kuv cov ntawv sau npe hauv zos?
Ib tus neeg koom tes OEM muaj peev xwm yuav tsum muaj peev xwm muab cov ntaub ntawv thev naus laus zis, Kev Tshaj Tawm Txog Kev Ua Raws Cai, tsab ntawv ceeb toom kev soj ntsuam, thiab cov ntaub ntawv sau npe yuav tsum tau ua rau feem ntau cov ntawv sau npe lag luam. Paub meej tias qhov kev lag luam uas lawv pawg tswj hwm muaj kev paub dhau los - kev txhawb nqa rau EU MDR kev xa tawm txawv ntawm ANVISA cov ntaub ntawv npaj, thiab tsis yog txhua tus neeg tsim khoom muaj peev xwm sib npaug ntawm ob qho tib si.
