Yuav luag txhua qhov kev ncua sij hawm ntawm cov khoom siv me nyuam tso tawm muaj tib zaj dab neeg tom qab nws: cov khoom tau npaj, ntim tau npaj, thiab tsis muaj ntawv pov thawj. Kev ua raws cai tsis yog ib kauj ruam ntawm qhov kawg ntawm qhov project - nws yog ib qho kev txwv uas tsim cov qauv tsim, tus neeg muag khoom xaiv thiab cov sij hawm los ntawm hnub ib.
Phau ntawv qhia no piav qhia txog tias daim ntawv pov thawj ua haujlwm li cas rau cov khoom siv pub rau menyuam yaus, qhov yuav tsum tau sib txawv ntawm Tebchaws Meskas, European Union thiab United Kingdom, thiab cov ntaub ntawv twg feem ntau yog cov chaw tsim khoom lub luag haujlwm piv rau tus neeg xa khoom.
Qhov no yog cov lus qhia siv tau rau cov hom phiaj kev npaj, tsis yog cov lus qhia kev cai lij choj. Cov kev xav tau hloov pauv thiab sib txawv ntawm cov khoom teeb tsa - lees paub qhov tshwj xeeb rau koj tus qauv thiab kev ua lag luam nrog koj tus kws kho mob ua ntej koj cog lus rau hnub tso tawm.
Pib Nrog Ob Lus Nug
Cov ntawv pov thawj txoj kev tsis raug xaiv los ntawm cov khoom qeb ib leeg. Ob lo lus nug nqaim yuav luag txhua rooj plaub:
| Lus nug | Vim li cas nws thiaj txiav txim siab txhua yam |
| Nws yog dab tsi, raug cai? | Ib qho khoom siv uas tau thov kev kho mob lossis lub hom phiaj kho mob ua raws txoj kev sib txawv ntawm cov khoom siv hauv tsev. Lub twj tso kua mis ua lag luam rau kev qhia mis yog kho txawv ntawm lub raj mis sov ua lag luam kom yooj yim. |
| Nws yuav muag qhov twg, thiab los ntawm leej twg? | Ncaj nraim hauv online, khw muag khoom thiab lub cev muag khoom txhua tus tsim cov ntaub ntawv sib txawv rau saum cov cai lij choj. Marketplaces nquag nug ntau dua li txoj cai. |
Tau txais ob lo lus teb no sau ua ntej koj nug ib tus neeg muag khoom rau cov lus hais. Lawv txiav txim siab seb daim ntawv pov thawj twg muaj feem cuam tshuam thiab qhov twg yog suab nrov nrov.
Tebchaws Asmeskas: FDA, FCC thiab Cov Khoom Muag Khoom Muag
| FDA 510 (k) tshem tawm | Siv qhov twg cov khoom raug tswj raws li cov khoom siv hauv Teb Chaws Asmeskas. Ib tug clearance npog antaus ntawv tshwj xeeb, tsis yog ib lub tuam txhab - yog li tus qauv naj npawb ntawm qhov kev tshem tawm yuav tsum phim cov qauv koj tab tom importing. Nug tus lej tshem tawm (tus lej K). |
| FDA tso npe thov | Lub chaw tsim khoom tau sau npe thiab nqa tus lej FEI. Qhov no yog qhov chaw-theem sau npe thiab tsis yog los ntawm nws tus kheej txhais tau tias cov khoom raug tshem tawm - ob qho tib si feem ntau tsis meej pem. |
| Hluav taws xob thiab EMC | Mains-powered thiab wireless khoom feem ntau xav tau kev nyab xeeb thiab electromagnetic compatibility kuaj thiab cov ntaub ntawv, tsis hais seb FDA txoj kev siv. |
| Cov ntaub ntawv thiab cov khoom siv me nyuam cov cai | Qhov twg cov khoom poob rau hauv cov menyuam yaus cov khoom siv lossis cov kev cai qhia txog tshuaj lom neeg hauv lub xeev, kev sim thiab tshaj tawm ntxiv tuaj yeem siv. Qhov no yog qhov uas tus khub ua raws cai tau txais lawv cov nqi. |
| Cov ntaub ntawv muag khoom thiab khw muag khoom | Feem ntau nruj hauv kev coj ua dua li txoj cai yam tsawg kawg nkaus. Npaj rau nws: daim ntawv teev npe tuaj yeem txwv tsis pub lub lis piam tom qab tso tawm yog tias daim ntawv ploj lawm. |
FIMILLA tuav FDA 510(k) cov qauv tshem tawm - piv txwv li tshem tawm K240218 - thiab ua haujlwm rau FDA-sau npe nrog FEI tus lej 3020034975.
European Union: CE, RoHS, EPR thiab MDR Cov Lus Nug
| CE kos npe | Yuav tsum tau siv rau cov lus qhia thiab cov kev cai. Txoj kev raug yog nyob ntawm cov khoom: low-voltage thiab EMC rau mains appliances, thiab ib tug kho mob txoj kev uas lub hom phiaj kho mob thov. |
| MDR lo lus nug | Yog tias koj ua lag luam cov khoom lag luam rau lub hom phiaj kev kho mob, Txoj Cai Kho Mob Kho Mob siv tau thiab cov luag num - cov ntaub ntawv kev, kev soj ntsuam kev soj ntsuam, ceeb toom rau lub cev kev koom tes - nce ntau. Tib yam khoom siv ua lag luam rau kev yooj yim tuaj yeem ua raws li cov khoom siv sib dua, uas yog qhov kev txiav txim siab ua haujlwm ntau npaum li ib qho engineering. |
| RoHS | Txwv tsis pub muaj kev phom sij hauv cov khoom siv hluav taws xob. Feem ntau yog them los ntawm cov lus tshaj tawm los ntawm cov saw hlau es tsis yog kev sim tag nrho cov khoom. |
| EPR | Extended producer lub luag hauj lwm luag hauj lwm rau ntim thiab cov khoom siv hluav taws xob, rau npe rau ib lub teb chaws. Qhov no yog lub luag haujlwm ntawm tus neeg xa khoom, feem ntau pom lig, thiab nws yog ib qho laj thawj vim li cas cov khoom xa tuaj. |
| WEEE thiab ntim | Kev sau npe thiab tshaj tawm cov dej num uas zaum nrog lub chaw tso khoom ntawm lub khw hauv txhua lub xeev cov tswv cuab. |
Cov tswv yim coj mus kuaj: CE yog txoj hauv kev, tsis yog daim ntawv nplaum. Nug seb cov lus qhia lossis kev tswj hwm lub cim tau siv rau hauv qab, thiab nug kom pom daim ntawv teev cov ntaub ntawv.
United Kingdom: UKCA thiab Post-Brexit Split
Lub tebchaws United Kingdom ua haujlwm rau nws tus kheej txoj cai tswjfwm, thiab cov cai lees txais tau raug txuas ntxiv mus ntxiv. Hauv kev xyaum koj yuav tsum paub meej txog txoj haujlwm tam sim no rau koj cov khoom tshwj xeeb ua ntej luam ntawv ntim, vim tias cov kev hloov pauv tau hloov ntau dua ib zaug.
Ob txoj kev npaj yuav tshwm sim. Ua ntej, UK thiab EU kev ua raws cai yog tam sim no cais cov haujlwm ua haujlwm, tsis yog ib qho - tsis txhob xav tias EU daim ntawv pov thawj suav nrog UK tshaj tawm. Qhov thib ob, ntim cov duab kos yog qhov kim tshaj plaws los hloov: nws feem ntau pheej yig dua kom paub meej tias cov cim yuav tsum tau ua ntej lub thawv luam tawm dua li rov luam dua tom qab.
Quality Systems thiab Social Audits
| ISO 13485 Kev Tswj Xyuas Kev Lag Luam | Kev tswj hwm tus qauv zoo rau cov khoom siv kho mob. Txawm tias qhov twg koj cov khoom tsis yog cov cuab yeej tswj hwm, qhov no yog daim ntawv pov thawj feem ntau coj los ua pov thawj tias lub Hoobkas khiav cov txheej txheem tswj tsis yog ad-hoc ib qho. |
| ISO 9001 Cov Ntawv Pov Thawj | Kev tswj hwm zoo. Feem ntau thiab muaj txiaj ntsig, tab sis nws hais tsis muaj dab tsi txog kev tswj cov cuab yeej tshwj xeeb - uas yog vim li cas cov neeg yuav khoom noj khoom noj feem ntau nug 13485. |
| GMP | Cov kev cai ntawm kev tsim khoom zoo, cuam tshuam qhov twg cov khoom lossis ntim khoom kov cov khoom noj lossis lwm yam kev cai ntawm kev nyiam huv. |
| BSCI thiab cov kev soj ntsuam zoo sib xws | Kev ua haujlwm thiab kev sib raug zoo. Ntau qhov kev xav tau ntawm cov khw muag khoom ntau dua li kev cai lij choj, thiab ib qho laj thawj uas tus neeg muag khoom dhau ntawm tus nqi thiab ua tsis tiav ntawm cov ntaub ntawv. |
FIMILLA tuav ISO 13485, GMP thiab BSCI, nrog rau CE / RoHS. Cov ntaub ntawv tag nrho yog teev nyob rau ntawm pebpatent thiab daim ntawv pov thawjnplooj.
Daim Ntawv Qhia Txog Kev Ua Lag Luam
| Yam khoom | Feem ntau cov chaw tsim khoom | Feem ntau cov importer tus |
| Cov cuab yeej tshem tawm / sau npe | Tuav lub clearance thiab lub chaw sau npe | Paub meej tias tus qauv cleared ntais ntawv uas yog imported |
| Hluav taws xob kev nyab xeeb & EMC | Cov ntawv ceeb toom thiab cov lus tshaj tawm ntawm cov khoom | Tshawb xyuas daim ntawv tshaj tawm npog qhov tseeb configuration thiab qhov chaw ua lag luam |
| Qhov system ntawv pov thawj zoo | ISO 13485 thiab Scope ntawm ntawv pov thawj | Txheeb xyuas daim ntawv pov thawj tam sim no thiab cov kev txwv npog cov khoom |
| Cov ntaub ntawv tshaj tawm | Cov ntaub ntawv kev sib cuag nrog zaub mov thiab daim tawv nqaij | Kev soj ntsuam tawm tsam lub khw muag khoom cov cai |
| EPR / WEEE sau npe | Muab cov khoom thiab ntim cov ntaub ntawv | Sau npeib lub teb chaws - qhov no tsis tuaj yeem raug xa mus |
| Daim ntawv lo thiab ntim khoom ua raws | Luam tawm rau qhov pom zoo kos duab | Pom zoo cov lus, cov cim thiab cov lus xav tau |
| Kev soj ntsuam kev sib raug zoo | Tuav daim ntawv txheeb xyuas thiab cov phiaj xwm kho kom raug | Paub meej tias nws npog qhov chaw tsim khoom siv tiag tiag |
Sau lub rooj ntawd thiab sau rau sab xis sab xis ua ntej koj tso daim ntawv xaj khoom. Txhua qhov khoob yog qhov kev pheej hmoo tso tawm.
Tsib Nqe Kev Tsis Txaus Siab
| "Lub Hoobkas tau ntawv pov thawj, yog li cov khoom muaj ntawv pov thawj" | Kev sau npe chaw thiab kev tshem tawm cov khoom lag luam yog qhov sib txawv. Cov neeg yuav khoom pom qhov no ntawm kev lis kev cai lossis ntawm cov npe tshuaj xyuas. |
| "CE npog UK ib yam nkaus" | Ob txoj kev cais cais nrog hloov kev lees paub. Txheeb xyuas txoj haujlwm tam sim no rau koj cov khoom. |
| "Certification yog ib kauj ruam ua ntaub ntawv thaum kawg" | Nws zaum ntawm txoj kev tseem ceeb thiab tuaj yeem rov pib qhov kev txiav txim siab tsim. Kev kuaj kuaj kab ib leeg tuaj yeem tshaj lub sijhawm siv. |
| "Peb lub khw tau pom zoo cov npe, yog li peb ua raws li" | Kev pom zoo hauv khw muag khoom thiab kev ua raws li txoj cai yog cais cov qauv, thiab cov khw muag khoom rov xyuas dua. |
| "EPR yog lub Hoobkas teeb meem" | Extended producer lub luag hauj lwm txuas mus rau lub chaw tso khoom ntawm lub khw. Qhov ntawd yog ib txwm koj. |
Yuav xaiv tus neeg muab khoom li cas uas tuaj yeem txhawb nqa kev ua raws cai
Daim ntawv pov thawj yooj yim dua rau kev npaj thaum koj cov chaw tsim khoom tau ua tiav ntau zaus. Cov cim los nrhiav:
| Daim ntawv pov thawj, tsis yog adjectives | Lawv muab koj tus lej FEI, tus lej tshem tawm, daim ntawv pov thawj - yam tsis raug thawb |
| Cov lus teb meej txog tus neeg xa khoom lub luag haujlwm | Lawv qhia koj tias lub luag haujlwm twg yog koj li, es tsis yog hais tias txhua yam yog tuav |
| Daim ntawv pov thawj hauv qhov project teem caij | Kev sim ua haujlwm sib npaug nrog cov cuab yeej, tsis yog tom qab tsim khoom |
| Ib txheej txheem hloov pauv | Ib qho khoom siv lossis cov khoom hloov pauv ua rau kev tshuaj xyuas ua raws, tsis yog kev tshuaj xyuas tus nqi xwb |
| Cov ntaub ntawv tob tob | 200+ patents thiab ib xyoo caum ntawm kev xa tawm, cov khoom pov thawj txhais tau tias tsawg dua cov teeb meem thawj zaug |
Peb piav qhia txog yuav ua li cas daim ntawv pov thawj haum rau hauv txoj haujlwm dav dua ntawm pebOEM txheej txheemnplooj ntawv, thiab tag nrho cov ntaub ntawv teev peb tuav yog teev nyob rau hauvpatent thiab daim ntawv pov thawj.
Cov lus nug nquag
Kuv puas xav tau FDA tshem tawm los muag lub raj mis sov hauv Asmeskas?
Nws nyob ntawm seb cov khoom lag luam li cas. Yog hais tias lub hom phiaj kho mob tau thov, lossis cov cuab yeej ua lwm yam poob rau hauv FDA txoj cai, kev tshem tawm thiab kev tso npe thov. Qhov twg nws raug muag raws li cov khoom siv hauv tsev, txoj kev sib txawv. Vim tias cov lus teb hloov nrog qhov chaw, kho qhov no ua ntej ua tiav cov ntawv thov ntim khoom.
Puas yog ISO 13485 xav tau, lossis tsuas yog zoo kom muaj?
Rau cov cuab yeej tswj hwm nws tau txais txiaj ntsig zoo. Rau cov khoom siv pub mis tsis muaj kev tswj hwm nws tsis yog kev cai lij choj hauv kev lag luam feem ntau - tab sis nws yog cov pov thawj feem ntau cov neeg yuav khoom thiab cov khw muag khoom siv los txiav txim seb lub Hoobkas puas tswj tau zoo, yog li nws ua haujlwm raws li kev lag luam yuav tsum tau ua.
Daim ntawv pov thawj siv sijhawm ntev npaum li cas?
Nws txawv ntawm txoj kev, kev ua lag luam thiab kev kuaj kab. Qhov kev npaj ua yuam kev tsis yog lub sijhawm - nws tau muab ntawv pov thawj tom qab tsim khoom hauv lub sijhawm. Khiav nws nyob rau hauv parallel nrog tooling thiab sampling.
Kuv puas tuaj yeem rov siv qhov kev tshem tawm uas twb muaj lawm?
Tsuas yog tias koj cov khoom yog lub cuab yeej tshem tawm. Kev tsim kho ntawm lub platform tshem tawm yog qhov tsim nyog thiab muaj txiaj ntsig zoo, tab sis kev hloov kho, cov khoom siv lossis kev npaj siv tuaj yeem txav koj mus rau sab nraud ntawm kev teeb tsa. Tau txais qhov kev txiav txim hauv kev sau ntawv los ntawm koj tus kws pab tswv yim ua raws cai.
Leej twg them rau daim ntawv pov thawj?
Feem ntau cov chaw tsim khoom npog cov txheej txheem zoo thiab cov khoom kuaj rau lawv tus kheej lub platform, thaum tus neeg xa khoom suav nrog kev lag luam tshwj xeeb rau npe thiab ib qho kev sim tshwj xeeb rau lawv cov teeb tsa. Pom zoo qhov kev sib cais hauv kev sau ntawv ua ntej qhov project pib - nws yog ib qho ntawm cov kev tsis sib haum xeeb lig.
Yuav ua li cas yog tias kuv tus neeg muag khoom tsis tuaj yeem muab daim ntawv pov thawj?
Kho nws raws li qhov tsis tsim nyog rau cov khoom tswj hwm. Rau cov khoom siv uas tsis muaj kev tswj hwm nws tuaj yeem ua haujlwm tau, tab sis kev ua raws li txoj haujlwm tom qab ntawd dhau los ua koj li, thiab nws yuav luag txhua zaus kim dua li them tus neeg xa khoom uas twb tau ua lawm.
Nug peb rau Daim Ntawv Teev Npe
Qhia peb cov khoom thiab lub hom phiaj ua lag luam. Peb yuav xa cov ntawv pov thawj peb tuav thiab sau cov luag num uas zaum nrog koj ua tus neeg xa khoom - ua ntej koj cog lus rau hnub tso tawm.
Thov Daim Ntawv Teev NpeKev Nyeem Ntawv
Daim ntawv pov thawj Scope nyob ntawm seb koj tsim nrog leej twg.Yuav Ua Li Cas Xaiv Lub Cev Lub Cev OEM / ODM Tus khubteeb tsa cov lus nug los nug ua ntej koj cog lus rau tus neeg muag khoom.
Ntawm cov khoom,Waterless vs Dej Da Dej Lub raj mis sovpiav qhia seb hom ntawv koj xaiv cuam tshuam li cas rau kev ua tau zoo thiab kev sim.
Peb tus kheej tshem tawm thiab cov ntaub ntawv xeem tau teev nyob rauPatent thiab Certificate.